Pharmaceutical Operator - FFEx AP (Environmental Monitoring)

The Position
Assist in developing the structure to aseptically operate Formulation, Wash/ Sterilization, Filling, and media preparations through documentation, start-up and validation activities for a new production facility.

Essential Functions
- Review and author Job Instructions, SOPs, and other documents
- Assist in the start-up and validation of new equipment
- Review standards to maintain aseptic areas, perform sanitizations, and environmental monitoring
- Support event response planning
- Assist maintenance team in developing protocols for restoration of lost function and predictive/preventative maintenance
- Support Subject Matter Experts (SMEs) in training fellow employees (including learning systems/equipment outside area of expertise)
- Follow all safety and environmental requirements
- Other duties as assigned

Qualifications
- High school diploma or equivalent (required)
- Minimum 2 years of experience in an FDA regulated environment (required)
- Aseptic processing experience (required)
- Isolator experience (preferred)
- Ability to read/write/understand complicated product documentation and SOPs with attention to detail (required)
- Computer literacy (required)
- Expertise in planning/organizing, managing execution, checking results, and revising work plan (preferred)

Benefits (as stated)
- Leading pay and annual performance bonus; 14 paid holidays; health/dental/vision effective day one; guaranteed 8% 401K contribution plus match; 14 weeks paid parental leave and 6 weeks paid family medical leave; tuition assistance; life/disability insurance; employee referral awards

Application Instructions
- Call 1-855-411-5290 for accommodation requests only.