Allentown-Bethlehem-Easton Area, PA
- Working knowledge of chemical and microbiological test methods.
- Working knowledge of various validation.
- Comprehensive process understanding.
- Identify process monitoring excursions per the documented control criteria.
- Work with cross-functional teams to investigate amd author process monitorimg excursions.
- Back-up to lead process monitoring weekly meetings with cross functiomal team. Maintain a communication pathway with the Antigen Leadership Group on process robustness and excursions.
- Basic statistics working knowledge and basic programming (JMP, SAS).
- Proficient Technical Writer, Project Management, Root Cause Analysis. Abiliity to interpret trends in data relative to process performance to drive more robust performance.
- Verbal and written communication skills.
- Adherence to commitment dates.
- Desire to work in fast-paced environment.
- Customer focused, results driven, Shop floor oriented.
- Self motivated.
- Demonstrated ability to be successful as a Leader of a diverse cross functional team.
- Detailed knowledge of cGMPs.
- 2+ Years Industry experience
- Working knowledge of chemical and microbiological test methods
- Working knowledge of various validations
- Comprehensive process understanding
- Successful candidate has a minimum of a 4 yr degree (Biology / chemistry / engineering / statistics)