Drug Product Manufacturing Technician II, Fill/Finish Operation

BeOne Medicines • Pennington, NJ • 10h ago

The Biotechnician II 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 Biotechnician II 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, 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

Equipment start-up, troubleshoot, and perform acceptance testing

Support the team by training other team members

Execute on the floor operations during clinical and GMP campaigns

Procedural design (SOP's, MBR's, etc.) and approval

cGMP Manufacturing

Equipment cleaning and sterilization

Solution preparation and transfer

Room and Equipment Cleaning

Equipment and process troubleshooting

Sterile Filtration / Integrity testing

Good Documentation Practices

Environmental Monitoring

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

Under the direction of the Production Supervisor, the Filling technician will work hands on, under ISO7, ISO8, ISO5 area and CNC with a variety of manufacturing production equipment and technologies

Education/Experience Required:

Bachelor's degree or 1+ years of GMP Manufacturing experience required

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

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