Description:FCAT is in the process of building a Cloud Based Brokerage Platform (Green Meadows), with the goal of positioning this platform as a system of record upon which systems of Innovation can provide path breaking client facing experiences.Cloud based horizontally scalable micro-service architecturePartnerships with like-minded technology platforms to leverage best of breedMinimized, Optimized and Flexible cost of operations
The Expertise You HaveExposure to the back-end systems for transaction processing and reconciliation w.r.t. cash management, PayPal / Venmo integration in a business/merchant account contextExposure to customer/transaction screening processes (AML, Fraud)Exposure to back-end Ops processes for Account ManagementBachelors Degree and minimum 5 to 8 years of experience working in an agile environment on business/product analysis, defining and communicating business requirements, writing user stories, and testing new featuresAbility to produce clear and concise business requirements, business process documents and support documentation using a flexible and adaptable approach, emphasizing creative/ innovative strategiesExperience with Lean Startup, Design Thinking, and Agile Methodologies and tools (Jira)The Purpose of Your RoleThe Business Analyst (BA) is a core team member at FCAT, working on one of our incubators for a particular new business opportunity.
Job Title: Post Market Surveillance AnalystLocation: Burlington, Massachusetts
Duration: 6+ months
Under the direction of the department manager or supervisor, will perform Post Market Surveillance duties. Will be expected to be able to demonstrate sound independent decision making in regards to global medical device reporting and other functions relating to the investigation of product complaints.
Job Duties:Supports complaint database upgrades, changes, conversions through design input, testing, maintenance functionsEnsures complaint information on intranet sites is maintainedSupport inspections by regulatory agencies (e.g. FDA, TUV) as requested Is vigilant of product complaint trendsEnsures department procedures and work instructions are maintainedCollaborate independently with other team members and departments needing product complaint informationAct as information resource to other Product Surveillance team membersBe able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department managementSupport CAPA investigations as they relate to complaint reportingBe able to ascertain when additional support may be needed from other teams or from supervision on complaint investigations (e.g.
Our client in Groton, CT, a leader in drug discovery and development, is seeking a Program Manager to join a team working on a crucial Business Technology project. This assignment will go through the end of this year and into Q1 of 2021. Our client is implementing a new Perkin Elmer ELN and needs the consultant to effectively coordinate with the PE team across a wide range of activities.This consultant would be required to manage a team, drive the BAs and architects during the upfront part of the project. Depending on decisions made regarding the solution, they would then shift to driving the entire implementation of the solution.
A Major Pharmaceutical Company is looking for Highly Qualified Investigator to support Corporate Employee Relations Dept.
The Client is seeking a highly qualified Investigator to support the Employee Relations Department. Under the direct supervision of the Head of ER / HR Compliance, the Investigator will conduct investigations into critical Employee Relations issues, provide training and support to others regarding investigations and perform other related duties. The role will also involve coordination with outside counsel and internal The Client functions across multiple geographies and functional areas, including Compliance, Internal Audit, etc. The position is an exciting opportunity to be a contributing member of an evolving and expanding Employee and Patient Experience focused organization in a growing global business.
Develop consistent approach and optimal practices around Employee Investigations
Serve as the investigator for complex, sensitive cases.
Engineer, Quality Attachments Sustaining Design Quality Engineer MAIN PURPOSE OF ROLE Summarize the main purpose of the role. A Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. MAIN RESPONSIBILITIES Execute and support on-time completion of Design Control Deliverables Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities Lead or support Risk Management activities from product Concept through Commercialization Support design test and inspection method development, and lead method validation activities Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps Support manufacturing process development & qualification for new product commercialization and product changes Support internal & external audit responses Support product re-certifications Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements Leads CAPA for design issues coming from manufacturing, complaints and improves design.
Job Title: Engineer, Supplier Development QualityLocation: Westford, Massachusetts, USADuration: 6+ months
Supplier Quality Engineer Job Description: Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 1. Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier. 2. Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
Job Title: Supplier Quality Engineer / Engineer, Supplier Development QualityLocation: Westford, MADuration: 6+ months
Lead CAPA investigation for supplier-attributed non-conformances for components and semi-finished sourced from outside suppliers and eliminates quality issues. Develops material qualification plan and material specifications for materials and implements processes at vendors. Identifies trends in supplier performances and improves supplier performances. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.Develops and/or sources inspection tools and equipment.Assists in generating component specifications.Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.;Analyzes incoming material defects.
Experis - Manpower Group is engaged with one of the largest Software Services Company. We are assisting the hiring manager to identify a talented Enterprise Software Sales Executive. It's a Full-time opportunity based out of Boston, MA.
Enterprise Software Sales Executive
Full time (Direct Hire)
The achievement of Sales targets, within margin and structural frameworks.
Maintain accurate and up-to-date sales pipeline and forecasts.
Promote, market and sell Company's software solution
Present and demonstrate the core functionality and benefits of the Company solutions.
Technical sales support will be provided when necessary from within the company.
Interface with the key teams within company such as Product Development, Project Delivery and Marketing - sharing market intelligence and potential sales opportunities.
Keep abreast of all competitor activity in the market, providing ongoing feedback to key product marketing and management teams.
Desired Skills and Experience
Hands on approach.
High levels of drive and energy.
15 years selling experience, with 10 years' experience selling Enterprise Software essential.
At least 3 years spent in current or previous sales role / organisation.
Experience with Salesforce.
Experience negotiating 500k multi-year contracts.
Having relationships and experience with companies within the waste management.
and recycling industry is a plus.
Experis is an Equal Opportunity Employer
Full-time, 40hrs/weekJob Summary:To assist in the implementation of environmental, health and safety (EHS) programs for manufacturing plant to ensure compliance, federal and state government regulations.Duties & Responsibilities:Project(s) will support business needs, and may include tasks in waste and chemical management, personal protective equipment assessments, worker safety evaluations, OSHA, EPA, and CT DEEP standards, Stormwater/Wastewater sample collection, as assigned.Qualifications:Formal Education/Field of Knowledge: B.S or science-related discipline.Experience/Proficiency Level: Entry level. Previous experience is preferred, but not required.Job Skills/Competencies: The employee primarily uses administrative skills to monitor and implement company safety/environmental data, interpret and apply policies, or produce standard reports. Required are coordinating, communication and basic leadership skills.Full-timet, 40hrs/weekJob Summary:To assist in the implementation of environmental, health and safety (EHS) programs for manufacturing plant to ensure compliance, federal and state government regulations.Duties & Responsibilities:Project(s) will support business needs, and may include tasks in waste and chemical management, personal protective equipment assessments, worker safety evaluations, OSHA, EPA, and CT DEEP standards, Stormwater/Wastewater sample collection, as assigned.Qualifications:Formal Education/Field of Knowledge: B.S or science-related discipline.Experience/Proficiency Level: Entry level.
The Equipment and Controls Technician (E&C Tech) is a great opportunity if you are an experienced Senior or Industrial Electrician, Electrical and Instrumentation Technician (E&I Tech), Engineer, Electric Technician, Instruments and Electric Tech or similar.Position Requirements:E&C Primary Purpose: Installs, inspects and maintains electrical power circuits and equipment, control and automation systems, electronic and pneumatic equipment used in pipeline, compressor stations, plant operations and measurement facilities. Duties and Responsibilities:- Perform all work in compliance with Company standards, procedures, and regulatory and tariff requirements.- Install, inspect, maintain, operate, troubleshoot, repair and calibrate various mechanical, pneumatic, hydraulic, electrical and electronic equipment, and complete all appropriate documentation associated with the duties using Company compliance systemsor applicable Company forms.- Inspect and Maintain electrical circuits and electrical equipment, which includes pumps, compressors, drivers, and auxiliary equipment.- Inspect and Maintain all control systems, emergency safety systems, electrical switch gear and power distribution infrastructure.- Identify, report, and correct safety and environmental concerns.
Experis is looking for a Fund Accountant for its major financial client in Boston, MA
The Fund Accounting Operations Analyst will be responsible for ensuring high quality NAV delivery. The successful candidate will partner with other lines of business and offshore partners providing oversight and support of daily production with an overall focus on accurate and timely delivery of daily NAVs.
Producing accurate and timely Net Asset Values
Producing ad hoc reports for clients
Performing quality assurance checks on information received internally from other supporting functions
Working closely with clients to resolve queries
Creating, maintaining and updating procedures for the funds
Ensuring compliance with all controls and procedures outlined in the procedures manual and general company policies
Working closely with the new business team and clients through the on-boarding process
Ensuring all schedule work is completed by agreed deadlines, checklists are signed and files contain all required supporting documents
Working with investment operations, reconciliations, shareholder services and financial reporting teams internally to agree internal deadlines to ensure external client deadlines are met
Identifying efficiencies and areas for improvement to reduce risk and become more efficient
Providing a premier client service by building strong relationships with the investment manager and any other third parties
2-7 years of experience in Fund Administration Operations
Have a thorough understanding of the theoretical and technical nature of mutual fund accounting and administration
Strong technical skills including accounting principles and theories
Ability to be effective in a global operating environment and a matrix management organizations
Excellent communication, influencing and negotiation skills with the ability to develop and maintain collaborative relationships both internally and with external clients
Analytical skills, problem solving, good critical thinking and decision-making skills
Experience working across multiple business areas and/or functions to deliver results
Excellent verbal and written communication skills; executive presentation skills
Ability to work independently and multitask in a fast paced environment
Relationship building skills - develop internal and external partnerships to drive results
Expert use of Microsoft Project, Word, Excel, PowerPoint, Visio and ability to present to senior management.
Experis is an Equal Opportunity Employer
Description:* Responsible for the creation, modification and maintenance of reports and visualizations incorporating data from the Quality Management System, R and Python (when applicable).* Responsible for documenting requirements, technical specifications and reference materials for reports and visualizations.* Provide input and expertise when required to support the continuous improvement to the R&D Quality Analytics program.
Skills Required:* Solid understanding of Microsoft Power BI, including the understanding of data relationships and using the data to design and develop effective visualizations and reports in Power BI Desktop, publishing to Power BI Web, versioning, security and managing performance concerns.* Solid understanding of R and Python including developing code and integrating with Microsoft Power BI visualizations.* Solid understanding of core database design principles and practices as well as a working knowledge of data warehouse best practices.* Excellent people skills.* Excellent written and oral communication skills.* Excellent problem solving.* Team work and time management.* Project management.* 2-3 years of experience of using Microsoft Power BI and 2-3 years of experience of programming with R and Python.* A working knowledge of SQL and reporting on data from major databases, such as Oracle is not required but would be a nice to have.
Additional Expectations:* Creating user friendly and insightful Microsoft Power BI reports and visualizations based on technical specifications.* Document technical specifications of all reports and visualizations.* Help develop and design applicable training material
Experis is an Equal Opportunity Employer
Title: IT Project Manager - PharmacovigilanceTimeline/duration: 6 months w/ possible extensionLocation: Remote start, then Cambridge,MA
The IT PV Project Manager will oversee IT projects supporting Pharmacovigilance (PV) systems. The Project Manager has responsibility for the health and success of projects within a matrixed organization with direct relationships with various groups in the business as well as IT.This role requires the ability to:Lead the creation of project business cases and vendor negotiationsMonitor, manage, and ensure predictable delivery of the project in a deadline-driven environment.Drive delivery and accountability of internal staff as well as vendors and third-party project managers. Own the quality of the project delivered.Enable early identification and appropriate escalation of risks and issues that require assistance, attention, or executive resolution.Effectively communicate project status to leadership, verbally or in written form.Experience with regulated systems projects, including requirements gathering, planning, and execution within a highly structured framework, and associated SDLCExperience working with third party vendor management (SaaS, business service partnersExperience with GxP Validation and CFR Part 11
Experience:5+ years project management experience, ideally including budget accountability8+ years experience as an IT professionalExperience with regulated systems projects, including requirements gathering, planning, and execution within a highly structured framework, e.g., GxPExperience with leading the contract work needed during planning phase of a project to get the vendor(s) in place to start the projectProven ability to motivate colleagues and manage stakeholder and workstream priorities in a deadline-oriented environmentStrong analytical and creative problem-solving skillsExcellent communication skills particularly organizing and presenting project information to managementCapable of working well under pressure; highly organizedCapable of working independentlyExperience working with third party vendor management
Education:BA or BS in Computer Science, Business, or Life Sciences-related field requiredPMP or equivalent credentials a plus
Experis is an Equal Opportunity Employer
(Laboratory Technician - Cell Culture/Upstream) Description: The candidate will be a member of the Viral Technology Flu support lab team and will be responsible for assisting with the execution of experiments within the process development laboratory. The candidate for this position will need to become trained on applicable production operations on the unit operations in the lab as well as general laboratory procedures. Following training, the candidate will be expected to independently execute assigned experiments with minimal direction from laboratory supervision. Key responsibilities will include: Assist in executing bioprocess operations in Cell Culture/Upstream. Recombinant baculovirus generation. Protein Expression in baculovirus insect cells system in shake flasks and 2-10L bioreactors.
SNFIJP00001783USA-Laboratory Technician II (Scientific)Description:The candidate will be a member of the Manufacturing Technology-DSP team and will be responsible for assisting with the execution of experiments within the downstream process development laboratory. The candidate for this position will need to become trained on applicable production operations on the unit operations in the lab as well as general laboratory procedures. Following training, the candidate will be expected to independently execute assigned experiments with minimal direction from laboratory supervision. Key responsibilities will include: Perform technical process operations for developmental lots. Execute process unit operations including: tangential flow filtration, centrifugation (continuous and batch), Chromatography and other purification technology.
The candidate will be a member of the Viral Technology Flu support lab team and will be responsible for assisting with the execution of experiments within the process development laboratory. The candidate for this position will need to become trained on applicable production operations on the unit operations in the lab as well as general laboratory procedures. Following training, the candidate will be expected to independently execute assigned experiments with minimal direction from laboratory supervision.
Key responsibilities will include:
Assist in executing bioprocess operations in Cell Culture/Upstream.
Recombinant baculovirus generation.
Protein Expression in baculovirus insect cells system in shake flasks and 2-10L bioreactors.
Cell line development, including thawing, sub-culturing, freezing, transfection and single-cell cloning, adaptation cell lines to serum-free condition, and suspension culture.
Perform technical process operations for developmental lots.
Execute process unit operations including tangential flow filtration, centrifugation (continuous and batch), virus inoculation and propagation, and sterile filtration.
In order to support process development operations, candidates will also be required to support various lab functions such as Solution and buffer preparation.
Equipment cleaning, assembly, and sterilization.
Sampling, sample login, transfer, and logging of results.
General lab duties such as general housekeeping and cleaning and inventory management.
The successful candidate will work with the Purification Process Development team in Biologics R&D and will be responsible for assisting with lab support activities. Responsibilities may expand to include supporting projects through the execution of purification experiments, analytics, or development studies, pending evaluation of performance. The candidate will be trained to operate within an R&D laboratory setting with an emphasis on safety and good laboratory practices. The Purification Process Development team is responsible for designing, characterizing, and optimizing purification operations for both early- and late- stage projects. Operations include various chromatography and filtration steps for the purification of protein products at the bench- and pilot-scale.
Linux Graphics Driver Engineer
LOCATION: Boxborough, MA
CONTRACT TERM: 6 months (with possibility of extension)
THE ROLE: The Linux Graphics Driver Software Engineer will be part of RTG (Radeon Technologies Group) graphics driver engineering team, working close to the GPU Hardware and Linux kernel on multiple high-performance graphics APIs including OpenGL and Vulkan driver development for GPU/APU products. The position will focus on Linux but also involve development on Windows. You will develop graphics drivers for next-gen of GPU/APU hardware and support nextgen of operation systems, including SW design, development, debugging problems and fixing issues.
THE PERSON: We are looking for a motivated engineer with strong expertise in software engineering and GPU technologies.
Title: Planview System OwnerTimeline/duration: 6 monthsLocation: Remote, then Cambridge, MA
Major Role: Platform Management
Minimum Experience Requirements:The Senior Planview System Owner will be the link between the technical and business views of the system by ensuring that the technical solutions being developed will satisfy the needs of the business.This position requires extensive current Planview Enterprise One PPM tool knowledge and configuration experience.* At a minimum must have experience configuring Planview Modules, specifically,* Planning: Portfolio Planning, Investment Planning, Capacity Planning* Demand: Project portfolio information, Other Planned Work
PPM years of experience* 10+ years of experience in large enterprise systems with rich business analysis and requirements gathering specific to complex integrated systems* 8+ years of experience in conducting business requirements sessions, writing business requirements and developing use cases* Minimum 5+ years of current experience in Planview* Expert in MS Office tools including MS Visio, MS Excel, MS PowerPoint* Understanding of financial and accounting practices especially experience in forecasting, budgeting and financial analysis combined with understanding of KPIs
Minimum Knowledge Requirements:
Project Manager-PharmaceuticalsContract/consultative position has Project Manager for "essential business' pharmaceutical company. Seeking PMO knowledge and FDA, 21 CFR, cGMP, experience.Duties: Follow PMO project management methodology. Develop the project scope statements for each project. Manage the day-to-day activities of the projects. Maintain and update the project plans. Manage each projects scope. Report project status on a weekly basis and communicate status to the key project participants and interested parties. Escalate unresolved issues and communicate decisions. Track the project budgets against the actual costs and forecast costs to completion. Develop a project risk plan for both projects and manage the project risks according to the plans.
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