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Aseptic Production Operator I

Ferring Pharmaceuticals

Ferring Pharmaceuticals

Parsippany-Troy Hills, NJ, USA
Posted on Oct 12, 2023

Job Description:

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.

Ferring US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be.

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 at work. From 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 just some of the ways we live our "People First" philosophy.

Responsibilities:

The Aseptic Production Operator I is responsible for sterilization equipment, line disinfection, equipment cleaning, component transfer, and aseptic fill finish batch production in critical cleanroom environment.

Perform aseptic processing tasks, including cleaning cGMP Areas, Parts Preparation Filter Integrity Testing sterilization, operating parts washers and autoclaves, perform tray loading and unloading, per wok instructions, standard operating procedures. Perform general material handling.

Set up, calibrate, and operate aseptic processing equipment such as isolators, filling machines, and autoclaves.

Assist with initial/subsequent validation of a new area, including manufacturing equipment and processes.

  • Collaborate with cross-functional teams, including Quality Assurance, Quality Control, and Maintenance to troubleshoot issues and resolve deviations.

  • Participate in aseptic process simulations, media fills, and equipment qualifications.

  • Participate in in-process inspections and quality control checks to verify the integrity of product quality.

  • Complete applicable logbook, form, and batch record documentation as required while adhering to strict cGMP and Good Documentation Practices.

  • Contribute to continuous improvement initiatives by identifying opportunities to enhance processes, reduce waste, and increase efficiency.

  • Complete initial aseptic gowning and process qualfication and maintain qualification to work within Grade A and Grade B cleaning environment.

  • 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; additional technical or vocational education is a plus.

  • Minimum 1 year experience working in the pharmaceutical/biopharma/biotech industry and within aseptic clean room environments.

  • Knowledge of aseptic gowning/ techniques, cleanroom protocols, and cGMP

  • Ability to read and comprehend work instructions and standard operating procedures

  • Proficient with Microsoft Office applications

  • Ability to understand equipment alarms and escalate as necessary

  • Exceptional attention to detail, accuracy, and documentation skills.

  • Ability to work in a controlled aseptic environment, following gowning and hygiene protocols.

  • Good communication skills and the ability to work collaboratively in a team-oriented environment.

  • Flexibility to work in shifts, including evenings, nights, weekends, and holidays, as required by production schedules.

  • Ability to stand for extended periods and perform repetitive tasks.

  • Lifting up to 25lbs, bending, and reaching to handle equipment and materials.

  • Wearing appropriate personal protective equipment (PPE) such as gowns, gloves, and masks.

  • Must be able to be medically cleared to wear full-face tight-fitting respirator based on OSHA Respiratory Protection Standard.

  • Meet minimal visual acuity requirements necessary for quality assessments in a production or packaging environment.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Ferring offers a competitive total compensation package inclusive of but not limited to the following benefits: medical, dental, vision, 401(k), vacation policy, paid holidays, sick days, paid maternity/paternity leave, tuition reimbursement, flexible savings accounts, short-term disability, long-term disability, life and AD&D insurance.

Location:

Parsippany, New Jersey