Validation Engineer
Posted on :
02-11-2022
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1 Vacancy
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Job Description
Req ID : 1748701
Job Title: Validation Engineer
Job Location: Framingham, MA.(Onsite Role)
Job Duration: Long-Term
Job Location: Framingham, MA.(Onsite Role)
Job Duration: Long-Term
Job Description:
- Leads and performs Commissioning, Qualification, and Validation (CQV) activities in support of early phase cGMP clinical manufacturing, fill finish, and QC laboratories.
- Assures validation activities are performed in accordance with applicable Standard Operating Procedures (SOPs), Company standards, industry best practices, and regulatory requirements.
- Performs validation program-related activities such as: DQ, IQ, OQ, PQ, CQ, RQ, etc.
- Generates and executes CQV protocols for facilities, utilities, equipment (e.g. Autoclaves, Chambers, Rooms, HVAC, etc.), and computerized systems (e.g. Delta V, HPLCs, Spectrophotometers, etc.).
- Performs basic data and statistical analysis (e.g. Temperature, Pressure, etc.).
- Generates complex CQV plans, traceability matrices, and qualification/technical reports.
- Generates qualification protocol deviations and non conformances.
MUST HAVE:
- 3+ Years of Direct hands-on experience with Validation & Chambers, Cold Rooms, & Incubators.
- Previous GMP in Pharma Industry experience
- Bachelors degree
- Experience with validation activities such as DQ, IQ, OQ, PQ, CQ, RQ
- Part 2 Compliance Delta V experience a BIG PLUS
Employment Type
Full Time
Key Skills
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