Operator Lead, Production; 2nd shift

Operator Lead, Production

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

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.

With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

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 work 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.

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and m working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are…