Operator Lead, Production (2nd shift)
About the role
As Operator Lead, Production, you will assume a senior Operator role within the aseptic manufacturing team. This position combines expert technical knowledge with leadership skills to oversee complex processes, mentor teams, and ensure the highest standards of sterility, quality, and compliance are met.
Ferring is a privately-owned, biopharmaceutical company that pioneers and delivers life-changing therapies to help people build families and live better lives. With a 70-year commitment to science and research, Ferring drives powerful discoveries and therapies to combat disease. Ferring US is Great Places to Work® Certified and has been recognized by Fast Company as one of “The World’s Most Innovative Companies” and by Fortune on its “Change the World List.”
Responsibilities
- Lead and execute complex aseptic processing tasks, including setup, sterilization, formulation, filling, and lyophilization, per work instructions, standard operating procedures, and batch record process steps.
- Operate, troubleshoot, and maintain advanced aseptic processing equipment such as isolators, filling machines, lyophilizers, and autoclaves.
- Provide mentorship, training, and guidance to junior, intermediate, and senior operators on aseptic techniques, equipment handling, process optimization, and compliance.
- Collaborate with cross-functional teams, including Quality Assurance, Quality Control, Engineering, and Production Management, to address deviations and drive process improvements.
- Lead and oversee aseptic process simulations, media fills, and equipment qualifications to validate process integrity, compliance, and robustness.
- Perform comprehensive in-process inspections and quality checks to ensure product quality integrity.
- Analyze, review, and approve batch records, process data, and documentation for accuracy, compliance, and adherence to cGMP (current Good Manufacturing Practices).
- Drive continuous improvement initiatives by identifying opportunities to optimize processes, reduce waste, and enhance operational efficiency.
- Maintain qualification to work within Grade A and Grade B cleaning environments and follow SOPs for gowning, cleaning, and sanitization.
- Comply with policies, guidelines, and regulatory requirements of the Quality System and applicable cGMPs.
- Perform other duties as required and assigned by management.
Requirements
- High school diploma or equivalent; technical or vocational education is preferred.
- 4+ years of experience working in the pharmaceutical/biopharma/biotech industry, specifically within aseptic clean room environments.
- Proficiency in aseptic techniques, cleanroom protocols, cGMP, and regulatory requirements.
- Mastery in operating, troubleshooting, and maintaining advanced aseptic processing equipment.
- Strong leadership skills, with the ability to mentor, develop, and inspire operators at various experience levels.
- Exceptional attention to detail, accuracy, and documentation skills.
- Proficiency in analyzing complex process data, deviations, and implementing corrective actions.
- Exceptional communication skills, with the ability to lead and collaborate across cross-functional teams.
- Flexibility to work in shifts, including evenings, nights, weekends, and holidays, as per production schedules.
Physical Requirements
- Meet minimal visual acuity requirements necessary for quality assessments in a production or packaging environment.
- Be medically cleared to wear a full-face tight-fitting respirator based on OSHA Respiratory Protection Standard.
- Ability to stand for extended periods, perform repetitive tasks, and work within a controlled aseptic environment.
- Lifting, bending, and reaching to handle equipment, materials, and products.
- Wear mandatory personal protective equipment (PPE) such as gowns, gloves, masks, goggles, and respiratory protection as required.
Pay
The base salary range for this role is $62,598 to $97,000. The actual amount paid may differ based on experience, knowledge, skills, abilities, education, and primary work location. If hired to work the 2nd shift, a 10% pay differential will apply. Additional compensation includes competitive annual incentive targets in the form of an annual bonus, based on individual and company performance.
Benefits
- Comprehensive healthcare (medical, dental, and vision) with a premium differential inverse to base salary.
- 401k plan with company match.
- Short- and long-term disability coverage and basic life insurance.
- Wellness benefits and reimbursement for certain tuition expenses.
- Sick time accrual of 1 hour per 30 hours worked.
- Vacation time accrual for full-time employees: up to 120 hours in the first four years of employment and 160 hours in the fifth year.
- 15 paid holidays per year.
- Paid parental leave, subject to a minimum period of employment at Ferring.