Operator Lead, Production (2nd shift)
About The Position
As a senior Operator within Ferring’s aseptic manufacturing team, the Operator Lead, Production combines advanced technical expertise and leadership to oversee complex aseptic processes, mentor operators, and maintain high standards of sterility, quality, and compliance. The role involves leading aseptic processing and equipment operation, supporting process validation and improvement, and ensuring accurate documentation under current Good Manufacturing Practices (cGMP). The position is based in Parsippany, New Jersey, and the posting identifies it as a second-shift role. Employees hired to work second shift receive a 10% pay differential. Ferring describes itself as a privately owned biopharmaceutical company focused on developing therapies that help people build families and live better lives. It emphasizes a people-first philosophy and offers competitive compensation, flexible benefits, personal support, and learning and development opportunities.
Requirements
- High school diploma or equivalent; technical or vocational education is preferred.
- At least 4 years of experience in the pharmaceutical, biopharmaceutical, or biotechnology industry and in aseptic cleanroom environments.
- Proficiency in aseptic techniques, cleanroom protocols, cGMP, and regulatory requirements.
- Mastery of operating, troubleshooting, and maintaining advanced aseptic processing equipment.
- Strong leadership skills and ability to mentor, develop, and inspire operators at different experience levels.
- Exceptional attention to detail, accuracy, and documentation skills.
- Ability to analyze complex process data and deviations and implement corrective actions.
- Exceptional communication skills and ability to lead and collaborate across cross-functional teams.
- Flexibility to work shifts, including evenings, nights, weekends, and holidays, according to production schedules.
- Meet minimum visual acuity requirements for quality assessments in a production or packaging environment.
- Be medically cleared to wear a full-face, tight-fitting respirator in accordance with the OSHA Respiratory Protection Standard.
- Ability to stand for extended periods, perform repetitive tasks, and work in a controlled aseptic environment.
- Ability to lift, bend, and reach while handling equipment, materials, and products.
- Ability to wear required PPE, including gowns, gloves, masks, goggles, and respiratory protection as required.
Nice To Haves
- Technical or vocational education.
Responsibilities
- Lead and execute complex aseptic processing tasks, including setup, sterilization, formulation, filling, and lyophilization, following work instructions, SOPs, and batch record steps.
- Operate, troubleshoot, and maintain aseptic processing equipment, including isolators, filling machines, lyophilizers, and autoclaves.
- Mentor, train, and guide junior, intermediate, and senior operators in aseptic techniques, equipment handling, process optimization, and compliance.
- Collaborate with Quality Assurance, Quality Control, Engineering, and Production Management to address deviations, improve processes, and execute aseptic processes successfully.
- Lead and oversee aseptic process simulations, media fills, and equipment qualifications.
- Perform in-process inspections and quality checks.
- Analyze, review, and approve batch records, process data, and documentation for accuracy, compliance, and adherence to cGMP.
- Identify and lead continuous improvement opportunities to optimize processes, reduce waste, and improve operational efficiency.
- Maintain qualification to work in Grade A and Grade B cleaning environments and follow gowning, cleaning, and sanitization SOPs.
- Comply with Quality System policies, guidelines, and applicable cGMP requirements.
- Perform other duties as required and assigned by management.
Benefits
- Comprehensive healthcare, including medical, dental, and vision coverage, with employee premium contributions varying inversely with base salary.
- 401(k) plan with company match.
- Short- and long-term disability coverage.
- Basic life insurance.
- Wellness benefits.
- Reimbursement for certain tuition expenses.
- Sick time of one hour per 30 hours worked.
- Vacation accrual for full-time employees: up to 120 hours during 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.
- Flexible benefits, personal support, and tailored learning and development opportunities.
- Annual incentive compensation in the form of an annual bonus, with payouts based on individual and company performance.
- 10% pay differential for employees hired to work second shift.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
