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MSEO Manufacturing Systems Validation Specialist
4 months ago
MSEO Manufacturing Systems Validation Specialist (Summit West, NJ - ONSITE)
We are looking to hire a candidate with the skill sets mentioned and experience for one of our clients within the pharmaceutical industry. This position is an Onsite role, M-F at the Summit West, NJ office site. This is a 6-month contract with the potential for extension, only local NJ candidates.
Job Summary:
The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works.
The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
Position Responsibilities:
The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant BMS procedures, such as CSV SOP but no limited and applicable health authority regulations.
- Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation.
- Understanding the concept of Critical thinking for Computerized Systems.
- Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties.
- Minimum 50% onsite required every week (Candidate is supposed to align the onsite days with the manager and be available onsite when the manager requests).
Required Skills/Experience/Education:
- 4+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
- Pharma background Required.
- Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
- Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
- Experience with MES infrastructure, ALM and Veeva document/change management systems, and middleware WebMethods.
- Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs).
- Advanced technical document writing and time management skills, including the ability to prioritize and manage expectations.
- Bachelor's degree required in Life Science or Engineering or Technology discipline is required.
- An equivalent combination of education, experience, and training may substitute.
Other job specifications:
- Employment Type: Contract to Hire (CTH), W2 only. NO C2C.
- Contracting Period: 6-month contracting opportunity with the potential for extension.
- Job Location: This is an Onsite role in Summit West, NJ. Need local candidates ONLY.
- Contract Rate/Salary: $55 on W2 hourly.
- Interview Process: Phone/Video Interview (s).
