Consultant, Subject Matter Expert, Sterility Assurance - Consumer Products, Pharmaceutical and Medical DevicesCOMPANY
Fortune 500 Life Sciences Company.ORGANIZATIONAL STRUCTURE
This Consultant will report to the VP of Sterility Assurance.CONTEXT
Our Fortune 500 Client manufactures consumer healthcare products, pharmaceuticals and medical devices. As the company continues to grow and expand, the Sterility Assurance area requires expertise from a qualified consultant, in potentially all three areas, specifically medical devices. This individual will focus on individual contributions in a collaborative environment.MUST HAVES:
LOCATION & TRAVEL
- 10+ years related business experience in large, global life sciences organizations, with a focus on medical devices preferred.
- Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for consumer product, medical device or pharmaceutical manufacturing facility.
- Technical skills in sterility reprocessing and validation of reprocessing for reusable medical devices.
- Demonstrated competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
- Understanding of the sterilization process microbiological lethality as it relates to both product design and sterilization processing.
- Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience.
- Experience with conducting technical assessments of in-house and contract sterilization processes or contract microbiological laboratories.
- A proven track record on trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results.
- A high level knowledge of standards including AAMI and ISO.
- A demonstrated ability to work in a collaborative/teamwork environment.
- Bachelor of Science in Microbiology, Biology, Engineering or related discipline. MS or PhD is preferred.
- 10+ years experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment.
- Ability to analyze large amounts of data specific to product design to write protocols and produce reports addressing trends or suggested changes.
- Proficient in tools like Excel, Word, PowerPoint and analytical software.
Northern NJ or northeastern PA with the ability to be onsite 50%. Some remote work possible. Local preferred.START & TERM
ASAP - 6 month initial contract, with probable extensions.