Operator Lead, Production

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.

Responsibilities:

• Lead and execute complex aseptic processing tasks, including setup, sterilization, formulation, filling, lyophilization, per work instructions, standard operating procedures and batch record process steps.
• Take charge of advanced equipment operation, troubleshooting, and maintenance of aseptic processing machinery such as isolators, filling machines, lyophilizers, and autoclaves.
• Provide mentorship, training, and guidance to junior, intermediate, and senior operators. Impart expert knowledge on aseptic techniques, equipment handling, process optimization, and compliance.
• Collaborate with cross-functional teams, including Quality Assurance, Quality Control, Engineering, and Production Management. Address deviations and drive process improvements, and ensure successful execution of aseptic processes.
• 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, ensuring the highest integrity of product quality.
• 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 overall operational efficiency. Provide guidance and direction for process enhancements.
• Maintain qualification to wok within Grade A and Grade B cleaning environment and follow Standard Operating Procedures (SOPs) for gowning, cleaning, and sanitization.
• Comply with policies, guidelines, and regulatory requirements of the Quality System and applicable current Good Manufacturing Practices (cGMPs).
• Other duties as required and assigned by management.

Requirements:

• High school diploma or equivalent; technical or vocational education is preferred.
• 4+ years experience working in the pharmaceutical/biopharma/biotech industry and within aseptic clean room environments.
• Proficient 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 able to be medically cleared to wear full-face tight-fitting respirator based on OSHA Respiratory Protection Standard.
• Extended periods of standing, repetitive tasks, and working within a controlled aseptic environment.
• Lifting, bending, and reaching to handle equipment, materials, and products.
• Wearing mandatory personal protective equipment (PPE) such as gowns, gloves, masks, goggles, and respiratory protection as required.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $62,598 to $116,253, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

Location:
Parsippany, New Jersey