Validation Engineer (Upstream/Downstream Equipment Process) - LS Solutions

Title: Validation Engineer (Upstream/Downstream Equipment Process)
Duration: 6 months + (Temp to Hire)
Location: Milford, MA 01757
Pay Rate-$60.00/hr on W2
Position Description:
Experienced with Upstream/Downstream process equipment qualification (i.e., Buffer Prep;
Media Prep; Bioreactors; Filtration System, etc.)
Lead small to medium sized projects activities including design review, startup, commissioning and qualification/validation activities of the new expansion BioPharma
manufacturing Center (RBMC) as well as the existing manufacturing operations involving
equipment (both process /amp; laboratory), facility, utilities qualification and computer system validation.

Demonstrate hands-on experience in developing and executing specifications,
operating procedures, commissioning/qualification/ validation (CQV) protocols and reports to maintain System invalidated state.

Provide expertise and support in the preparation, review and execution of CQV documentation deliverables for contract development and manufacturing organization (CDMO) at Rentschler Biopharma SE, Milford, MA.
Required Skills:
Minimum education - Bachelors degree in Engineering, Life Sciences, or related discipline
(Chemical Engineering, Chemistry, Biology, Electrical, Mechanical, etc.).
Experienced with Upstream/Downstream process equipment qualification (i.e., Buffer Prep;
Media Prep; Bioreactors; Filtration System, etc.)
Minimum of 5 years of hands-on, direct validation experience in pharmaceutical / biotech
industries.
Good knowledge in writing, reviewing and executing CQV validation protocols and technical reports (including user/functional/design specifications/traceability matrices, etc.).
Employment Type: Contractor