Operator Lead, Production

Ferring Pharmaceuticals•Parsippany, NJ

6d•Onsite

About The Position

As Operator Lead, Production, you will assume a senior Operator role within the aseptic manufacturing team. The position combines expert technical knowledge with leadership skills to oversee complex processes, mentor teams, and ensure the highest standards of sterility, quality, and compliance. You will lead aseptic processing and equipment operations, support and develop other operators, collaborate across functions, and help ensure compliance with cGMP and regulatory requirements. The role is located in Parsippany, New Jersey.

Requirements

High school diploma or equivalent.
At least 4 years of experience in the pharmaceutical, biopharma, or biotech 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 various 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 necessary for quality assessments in a production or packaging environment.
Be medically cleared to wear a full-face, tight-fitting respirator under 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 to handle 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, according to work instructions, standard operating procedures, and batch record steps.
Operate, troubleshoot, and maintain advanced aseptic processing machinery, 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, drive process improvements, and ensure successful aseptic process execution.
Lead and oversee aseptic process simulations, media fills, and equipment qualifications to validate process integrity, compliance, and robustness.
Perform in-process inspections and quality checks to protect product quality.
Analyze, review, and approve batch records, process data, and documentation for accuracy, compliance, and adherence to cGMP.
Identify opportunities to optimize processes, reduce waste, and improve operational efficiency; provide guidance for process enhancements.
Maintain qualification to work within Grade A and Grade B cleaning environments and follow SOPs for gowning, cleaning, and sanitization.
Comply with Quality System policies, guidelines, and applicable cGMP and regulatory requirements.
Perform other duties as required and assigned by management.

Benefits

Competitive total compensation.
Flexible benefits and personal support.
Tailored learning and development opportunities.
Medical, dental, and vision coverage, with employee premiums 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.
40 hours of sick time frontloaded yearly, or more where required by state or local law.
For full-time employees, 112.5 to 150 hours of vacation accrued yearly during the first four years, with additional accruals beginning in the fifth year.
12 to 13 paid holidays per year.
20 weeks of paid parental leave.
A 10% pay differential for employees hired to work second shift.