Operator I, Production
Ferring Pharmaceuticals
Summary
As Operator I, Production you will be responsible for sterilization equipment, line disinfection, equipment cleaning, component transfer, and aseptic fill finish batch production in critical cleanroom environment.
Job description
Responsibilities
- Perform aseptic processing tasks, including cleaning cGMP Areas, Parts Preparation, Filter Integrity Testing, sterilization, operating parts washers and autoclaves, and tray loading and unloading per work instructions and 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 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 cGMPs.
- Flexibility to work weekends and holidays, as required by production schedules.
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.
- 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.
- 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.
- Ability to stand for extended periods and perform repetitive tasks.
- Lifting, bending, and reaching to handle equipment and materials.
- Wearing appropriate personal protective equipment (PPE) such as gowns, gloves, and masks.
Requirements
- High school diploma or equivalent
- Minimum 1 year experience in pharmaceutical/biopharma/biotech industry
- Experience in 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 ability to work collaboratively in a team-oriented environment
- Flexibility to work weekends and holidays
- Meet minimal visual acuity requirements
- Medically cleared to wear full-face tight-fitting respirator per OSHA Respiratory Protection Standard
- Ability to stand for extended periods and perform repetitive tasks
- Lifting, bending, and reaching to handle equipment and materials
- Wearing appropriate personal protective equipment (PPE)
Benefits
- Medical, Dental & Vision
- 401(k) Plan
- Company 401(k) Match
- Short-Term Disability
- Long-Term Disability
- Basic Life Insurance
- Wellness Benefits
- Tuition Reimbursement
- Paid Sick Time
- Paid Vacation
- Paid Holidays
- Paid Parental Leave
Company overview
Ferring Pharmaceuticals is a Swiss multinational biopharmaceutical company specializing in reproductive health, maternal health, gastroenterology, and urology. Founded in 1950 by Dr. Frederik Paulsen Sr. and Dr. Eva Paulsen in Malmö, Sweden, the company has grown into a global leader with headquarters in Saint-Prex, Switzerland. Ferring employs over 7,000 people worldwide and operates in more than 50 countries, marketing its products in over 100 countries. The company is privately owned and research-driven, with a strong commitment to building families and helping people live better lives. Ferring has been developing treatments for mothers and babies for over 50 years and is at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. The company's portfolio includes leading products such as Menopur for reproductive medicine, Pentasa for gastroenterology, and Adstiladrin for bladder cancer treatment. With manufacturing facilities across Europe, South America, China, India, and the United States, Ferring maintains a robust global presence while maintaining its focus on specialty biopharmaceuticals that address significant unmet medical needs.