$28.00 - $34.00/hour
This position is responsible for validation activities in a cGMP /CBER regulated medical device manufacturing environment. As a member of the Design Transfer and Technical Support Team, this position will participate in Process Validation activities including preparation of validation documents such as protocols, final reports and plans.
- This candidate will be responsible for preparing, reviewing and/or approving validation documents to support new product launches and any changes to existing validated processes for regulated on-market products.
- These validations may include the manufacturing and filling processes for bulk reagents (large and small scale) and for production intermediates such as Oligonucleotides, Control Stocks and Enzymes.
- Duties include: the preparation of validation plans, protocols and reports, analysis of data, and developing validation strategies in accordance with industry guidelines and SOPs.
- This position must be able to lead validation deliverables / projects, manage multiple competing timelines and priorities and work in a cross-functional team.
- 1-3 years experience in manufacturing, preferably in a biotech or diagnostic equipment industry, required.
- 3-5 years experience in manufacturing, preferably in a biotech or diagnostic equipment industry with validation experience, preferred
- Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
- Demonstrated troubleshooting and problem solving skills including the use of designed experiments.
- Strong teamwork and communication skills.
- Experience with Microsoft Office, MiniTab and statistical analysis and PCR technology, preferred.