Operator I, Production

Ferring Pharmaceuticals•Parsippany, NJ

4d•$34,364 - $63,820•Onsite

About The Position

As an Operator I, Production at Ferring, you will support aseptic fill-finish batch production in a critical cleanroom environment. The role is responsible for sterilization equipment, line disinfection, equipment cleaning, and component transfer. You will prepare and operate aseptic processing equipment, support validation and qualification activities, inspect processes and products, and maintain accurate documentation in accordance with cGMP and Good Documentation Practices. The position requires maintaining qualification to work in Grade A and Grade B cleaning environments and flexibility to work weekends and holidays as production schedules require.

Requirements

High school diploma or equivalent.
At least 1 year of experience in the pharmaceutical, biopharmaceutical, or biotechnology industry and in aseptic cleanroom 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 them as necessary.
Exceptional attention to detail, accuracy, and documentation skills.
Ability to work in a controlled aseptic environment while following gowning and hygiene protocols.
Good communication skills and ability to work collaboratively in a team-oriented environment.
Flexibility to work weekends and holidays as required by 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 and perform repetitive tasks.
Ability to lift, bend, and reach to handle equipment and materials.
Ability to wear appropriate personal protective equipment, including gowns, gloves, and masks.

Nice To Haves

Additional technical or vocational education.

Responsibilities

Perform aseptic processing tasks, including cleaning cGMP areas, parts preparation, filter integrity testing and sterilization, operating parts washers and autoclaves, tray loading and unloading according to work instructions and standard operating procedures, and general material handling.
Set up, calibrate, and operate aseptic processing equipment, including isolators, filling machines, and autoclaves.
Assist with initial and subsequent validation of new areas, manufacturing equipment, and processes.
Collaborate with 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 product quality and integrity.
Complete applicable logbooks, forms, and batch records while following cGMP and Good Documentation Practices.
Identify opportunities to enhance processes, reduce waste, and increase efficiency as part of continuous improvement initiatives.
Complete initial aseptic gowning and process qualification and maintain qualification to work within Grade A and Grade B cleaning environments.
Comply with Quality System policies, guidelines, and applicable cGMP requirements.
Work weekends and holidays as required by production schedules.
Perform other duties as assigned by management.

Benefits

Comprehensive healthcare coverage, including medical, dental, and vision insurance, with an employee premium differential based inversely on base salary.
401(k) plan and company match.
Short- and long-term disability coverage.
Basic life insurance.
Wellness benefits.
Reimbursement for certain tuition expenses.
Sick time accrued at 1 hour per 30 hours worked.
Vacation accrual for full-time employees, up to 120 hours during the first four years of employment and 160 hours in the fifth year.
15 paid holidays per year.
Paid parental leave, subject to a minimum period of employment at Ferring.
Annual incentive compensation in the form of an annual bonus, with payouts based on individual and company performance.
Flexible benefits, personal support, and tailored learning and development opportunities.
Working hours that respect employees' lifestyles.