Validation Engineer – Biopharma Equipment (JP5140)
Woburn, MA 01801
ARI Manufacturing Upstream Operations
Initial 6 moths with likely extension(s)
3Key Consulting is looking for a Validation Engineer ideally with background in equipment validation, demonstrated knowledge and experience in equipment validation, and 3+ years of experience in equipment validation,
for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
Primarily responsible for ensuring adherence to commissioning and qualification standards and procedures for computer related systems. Responsibilities include perform routine technical tasks such as the planning, generation, execution and closure of validation documents for manufacturing and laboratory systems. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the Validation and Quality functions, provides testing guidance, and provides timely and effective response and follow-through in the resolution of validation issues.
Under general supervision will evaluate, select and apply standard validation techniques and procedures to support completion of project deliverables that meet quality standards and defined schedules.
Top Must have Skill Sets
Employee Value Proposition:
- Equipment validation experience
- Autoclave validation
- Technical writing
The Amgen reputation is high in the area specifically surrounding compliance with regulations. This is drug substance and drug product operations facility. Not many people can say they've supported this equipment and processes.
: No equipment validation experience. Only experience with computer validation.
On site interview. Able to begin interviewing starting 1/7. Will begin scheduling interviews starting 12/21.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.