Aseptic Production Operator I — Cleanroom

Ferring Pharmaceuticals Inc.; Parsippany-Troy Hills (NJ); On-site; USD 34,000 - 64,000; Full time

Job summary

Ferring Pharmaceuticals Inc. in Parsippany, New Jersey is seeking an Operator I, Production to operate sterilization equipment, perform aseptic fill finish tasks, and maintain strict cleanroom standards.

You will work with cGMP practices, contribute to ongoing process improvements, and collaborate with QA, QC, and Maintenance to resolve deviations. The role requires capable handling of logbooks and batch records in a regulated environment.

Qualifications

• High school diploma or equivalent; technical education is a plus.
• Minimum 1 year experience in pharmaceutical/biopharma/biotech aseptic clean room environments.
• Knowledge of aseptic gowning/ techniques, cleanroom protocols, and cGMP.
• Ability to read and comprehend work instructions and standard operating procedures.
• 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 weekends and holidays, as required by production schedules.
• 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.

Responsibilities

• 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.
• 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 qualification 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).
• Flexibility to work weekends and holidays, as required by production schedules.
• Other duties as required and assigned by management.

Skills

Aseptic gowning

cGMP

Documentation

Attention to detail

Team collaboration

Troubleshooting

Education

High school diploma

Job description

Ferring Pharmaceuticals Inc. in Parsippany, New Jersey is seeking an Operator I, Production to operate sterilization equipment, perform aseptic fill finish tasks, and maintain strict cleanroom standards.

You will work with cGMP practices, contribute to ongoing process improvements, and collaborate with QA, QC, and Maintenance to resolve deviations. The role requires capable handling of logbooks and batch records in a regulated environment.