About the position
The Fill/Finish Manufacturing Technician III position will work in a cleanroom environment and follow cGMP batch records and SOPs to manufacture drug products. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). Employees will prepare suites for manufacturing operation and operate in a safe and compliant manner. The primary responsibility of the Fill/Finish Technician III will be to participate in the execution of all phases and facets of drug product formulation, filling, visual inspection, labeling, and packaging. This will include requesting materials, setup, preparation, final filtration, and formulation, filling vials inside a Grade A isolator with an automated filling machine, labeling, visual inspection, packaging, document review.
Responsibilities
- Support all site validation protocol execution and report generation
- Technical contact for team, customers, and vendors
- Support the team by coaching and training other team members
- Execute on the floor operations during clinical and GMP campaigns
- Enhance the safety of the organization through process/equipment improvements
- Part of equipment design and purchase
- Equipment start-up, troubleshoot, and perform acceptance testing
- Procedural design (SOP’s, MBR’s, etc.) and approval
- Write, initiate and review deviations
- Batch Record review
- Support drafting change record and CAPAs
- cGMP Manufacturing Equipment cleaning and sterilization
- Solution preparation and transfer
- Equipment and process troubleshooting
- Sterile Filtration / Integrity testing
- Good Documentation Practices
- Autoclaves and washers (equipment prep, cleaning and sterilization)
- Familiar with Vial washer, Tunnel, Filling, Inspection and Packaging DP equipment set up
- Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace
Requirements
- High school education or GED required
- Bachelor’s degree / Associate degree / Vocational school Preferred
- Demonstrated ability to successfully gown into aseptic manufacturing areas
- Excellent organization and time-management skills required
- Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure
- Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed
- Works with a sense of urgency, while engaging and listening to experts
- Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills
- Strong organizational skills with the proven ability to prioritize
- Must be dependable and punctual
- Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word
- Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs
Nice-to-haves
- Prior industry or related field experience
- Familiarity with computer-based systems
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
