Biotechnician I

BeiGene • Hopewell, NJ

8d • Onsite

About The Position

The Biotechnician I 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 I will be to participate in the execution of all phases and facets of drug product formulation, filling, lyophilization, 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, lyophilization, labeling, visual inspection, packaging.

Requirements

• 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
• Customer/Client Focus
• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Nice To Haves

• N/A

Responsibilities

• Equipment start-up, troubleshoot, and perform acceptance testing
• Execute on the floor operations during clinical and GMP campaigns
• 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 parts washers (equipment prep, cleaning and sterilization)
• 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
• Prepare suites for manufacturing operation and operate in a safe and compliant manner
• Participate in the execution of all phases and facets of drug product formulation, filling, lyophilization, visual inspection, labeling, and packaging
• Requesting materials, setup, preparation, final filtration, formulation, filling vials inside a Grade A isolator with an automated filling machine, lyophilization, labeling, visual inspection, packaging

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• Discretionary equity awards
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed