Operator Lead, Production

Ferring•Parsippany, NJ

4d•Onsite

About The Position

Ferring is seeking an Operator Lead, Production to serve as a senior Operator within its aseptic manufacturing team. The role combines advanced technical expertise and leadership to oversee complex production processes, mentor operators, and maintain high standards of sterility, quality, and regulatory compliance. The position is located in Parsippany, New Jersey. The Operator Lead performs and oversees aseptic processing activities, operates and troubleshoots specialized equipment, supports operator training, collaborates with cross-functional teams, and reviews production documentation. The role also leads process validation activities and continuous improvement efforts while maintaining qualification to work in Grade A and Grade B cleanroom environments. The position requires flexibility to work shifts, including evenings, nights, weekends, and holidays, according to production schedules. Physical duties include extended standing, repetitive tasks, handling equipment and materials, and wearing required protective equipment. Candidates must meet visual acuity requirements and be medically cleared to wear a full-face, tight-fitting respirator. Ferring describes its compensation package as including a salary range, annual incentive compensation, benefits, and a 10% pay differential for second-shift work. The salary range is shown as placeholders: $[000,000] to $[000,000]. The role’s benefits include healthcare, retirement matching, disability and life insurance, wellness benefits, tuition reimbursement, sick and vacation time, paid holidays, and paid parental leave.

Requirements

High school diploma or equivalent.
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 under the OSHA Respiratory Protection Standard.
Ability to stand for extended periods, perform repetitive tasks, work in controlled aseptic environments, and 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, 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.
Address deviations, drive process improvements, and ensure successful execution of aseptic processes.
Lead and oversee aseptic process simulations, media fills, and equipment qualifications.
Perform in-process inspections and quality checks to protect product quality.
Analyze, review, and approve batch records, process data, and documentation for accuracy and cGMP compliance.
Identify opportunities to optimize processes, reduce waste, and improve operational efficiency; guide process enhancements.
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 and regulatory requirements.
Perform other duties as assigned by management.

Benefits

Comprehensive healthcare coverage, including medical, dental, and vision, with employee premium contributions that vary 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.
Vacation accrual of 112.5 to 150 hours yearly for full-time employees 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.
10% pay differential for second-shift work.
Annual incentive compensation targets.