Responsibilities
- Carry out tasks defined in standard operating procedures and batch documentation.
- Apply solid hands-on and conceptual understanding in daily operations.
- Complete all required documentation per process transfer, validation, SOP, and batch record guidelines.
- Address routine challenges by applying known methods with fresh perspectives.
- Follow safety policies, quality systems, and current Good Manufacturing Practices in all activities.
- Finish assigned training to maintain technical proficiency and regulatory knowledge.
- Train team members on SOPs and work instructions to ensure successful production execution.
- Assist in root cause analyses and related investigations.
- Propose novel approaches to improve processes or solve issues.
- Help prepare manufacturing spaces and set up equipment or fixtures.
- Participate in commissioning facilities and production equipment.
- Develop technically accurate manufacturing procedures that support efficient operations and meet cGMP standards.
- Provide ongoing training on SOPs and work instructions for manufacturing tasks.
- Coordinate with production planning to manage daily operations across multiple shifts, including staffing, material, and product movement.
- Operate within cleanroom settings and perform aseptic techniques.
- Maintain environmental controls by conducting scheduled disinfection routines to meet global regulatory standards for particulate and microbial levels.
Benefits
- Comprehensive medical, dental, vision, and prescription coverage.
- Wellness programs including mental health support and employee assistance resources.
- Financial wellness tools and retirement savings plan with 401(K) options.
- Protective benefits including short- and long-term disability, life insurance, supplemental health coverage, travel protection, and survivor benefits.
- Work-life balance initiatives such as paid national and optional holidays, annual shutdown days, up to 120 hours of paid vacation, two paid volunteer days, sick leave, and flexible summer hours.
- Leave options for parental, caregiver, bereavement, and military responsibilities.
- Family support including reimbursement for adoption and surrogacy, fertility care benefits, resources for nursing travelers, and assistance with child, elder, and pet care.
- Additional offerings like tuition reimbursement and formal recognition programs.
Work Arrangement
On-site
Work Arrangement
This role requires full-time presence at the assigned site with no remote option.
Other
- Available shifts include rotating night shifts covering holidays and weekends, from 6:00 PM to 6:00 AM.
- On-site roles must be performed entirely at the facility with no remote alternative.
- Daily use of personal protective equipment is mandatory, including safety footwear, eyewear, aprons, face shields, lab coats, full-body gowns, hairnets, gloves, and hearing protection.
- Ability to work in a cleanroom and perform aseptic processing is required.
- Comfort with exposure to human blood components is necessary.
- Tolerance for proximity to strong magnetic fields is required.
- Applicants may request reasonable accommodations before accepting an offer.
- Full vaccination against Covid-19 and adherence to booster schedules is strongly encouraged.
- The company considers candidates with arrest or conviction records in compliance with applicable laws.
