Bio-Process Manufacturing Operator I

Katalyst-Healthcares-; Vacaville (CA); Sur place; USD 25 000 - 39 000; Plein temps

Résumé du poste

Creative Solutions Services, LLC in Vacaville, CA seeks a production operator to interface with automated systems in a cGMP setting. You will help produce bio-therapeutic medicines, maintain inspection-ready records, and follow SOPs in a fast-paced facility.

The role involves working in Upstream/Downstream areas, adhering to safety rules, and supporting manufacturing to meet production demands. High school diploma or GED required; mechanical background preferred.

Qualifications

• High School Diploma or GED required.
• Mechanical background or hands-on experience preferred for entry into biopharma.
• Advanced coursework or technical degree/certification is preferred.

Responsabilités

• Operate automated production systems in a cGMP environment.
• Maintain records to comply with cGMP and SOP.
• Participate in routine production of mammalian cell culture products.
• Follow safety and environmental guidelines; report incidents.
• Prepare materials for production; ensure Right-First-Time documentation.
• Escalate process issues to enable timely resolution.
• Use automation to perform production and equipment operations.
• Support Manufacturing to meet production demands.
• Assemble and prepare equipment for production; work with tanks/filtration.

Connaissances

Mechanical background

Formation

High School Diploma or GED

Description du poste

Summary:

• Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:
• Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.
• Downstream Manufacturing (DM): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; handle and aliquot hazardous materials.
• Follow established safety and environmental guidelines and procedures for all work performed.
• Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
• Responsibilities:
• Fosters safe work practices
• Operate systems that clean and sterilize tanks and filtration systems.
• Prepare materials for the production process.
• Exhibit detail-oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
• Escalate process issues as necessary to ensure resolution of issue
• Comply with cGMP, SOP and manufacturing documentation.
• Use automation to perform production and equipment operations.
• Provide support to Manufacturing to meet production demands.
• Assemble and prepare equipment for production.
• Communicate effectively and professionally in a team environment.

Education & Experience:

• Minimum Requirement: High School Diploma or GED.
• We Welcome Diverse Backgrounds: This is an excellent opportunity for:
  • Motivated individuals with a mechanical background/hands-on experience looking to transition into a new industry.
  • Current college students (Junior, Technical, or Community College) looking for a stable night shift.
• Preferred Qualification: Some advanced college-level coursework or a technical degree/certification is highly preferred.

Competencies:

• Compliance & Process-Oriented: Must be able to thrive in a highly regulated, fast-paced environment. We are looking for individuals who strictly follow established standard operating procedures (SOPs) and prioritize compliance over "improvising " or trying to solve complex process steps without guidance.
• Resilience & Problem Solving: Ability to adapt and maintain a strong work ethic when facing operational challenges.

Work Environment/Physical Demands/Safety Considerations:

• Must be able to work weekends, off-shifts, and overtime as required.
• No make-up or jewelry can be worn when working in the clean room environment.
• Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems.
• Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.
• Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.
• Handle and work with hazardous materials and chemicals per OSHA guidelines.
• Usage of hearing protection and dust masks may be required.
• Expected to be on feet standing or walking for up to 90% of shift.
• Travel up to 30 flights of stairs each shift to maneuver within the facility.
• Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems.
• Lift up to 40lb(18.2kg) loads multiple times per shift and carry up to 30 lbs(13.6kg). Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift.
• Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift.
• Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).
• In order to operate powered industrial trucks, employee must pass a DOT Physical which includes Blood Pressure <140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver's License.