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.
Bachelors degree in science, engineering or related field, or equivalent combination of education and work-related experience, required.
Masters degree, preferred.
College grads are encouraged.