5481 Manufacturing Commissioning & Qualification Technician

Onsite: Oceanside, CA

Job Summary

• The Manufacturing Commissioning & Qualification (C&Q) Technician position at the company is the equivalent to and is a part of the manufacturing technician job family.
• This role would be equivalent to a senior or master technician position.
• The Manufacturing C&Q Technician is an integral member of the OSUT (Oceanside Single Use Technology) team in Oceanside. The OSUT is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 3 clinical trials and commercial products. The OSUT will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility.
• We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset.
• Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production.
• The team members will work closely with the existing staff in the stainless steel operations as well as with South San Francisco Clinical Supply Center (CSC).

Duties:

• In this role the qualified individual will be part of the Operations, Process Support and Process Engineering team that starts up the facility.
• There will be one team that will support the entire process from initial cell bank thaw through bulk freeze. Team members will support manufacturing operations upstream and downstream but will also have responsibility for technical evaluations, troubleshooting, and work with the project team on equipment or consumable design.
• The candidate will engage with customer groups, network teams and project teams to seek opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.

Duration and Potential Extension:

• The role requires 100% time commitment at site Oceanside through the end of 2024 with potential extension based on the development and achievement of deliverables.
• The high-level work outcomes are:
• Process equipment installed per design.
• Start-up, Commissioning, and Qualification activities completed on schedule.
• OSUT Manufacturing Core is fully qualified up to OQ and can be released for GMP use.

Deliverables and Milestones

• Successful Automation SAT completion
• Completion of Operation Verification
• Successful Water Run for Process Equipment completion
• Successful Technical Run for Process Equipment completion

Primary Responsibilities:

• Interfacing with highly automated production systems and controls in cGMP manufacturing environment.
• Assemble, prepare, and operate equipment for manufacturing operations, including cell culture or purification (e.g. culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer).
• Performs media/buffer solution preparation operations.
• Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).
• Troubleshoot and investigate complex problems, and work with others to implement solutions.
• Participates in safety assessments/reviews.
• Ensures necessary operating procedures are in place prior to C&Q execution on the assigned unit operation(s).
• Ensures training materials and curriculum are developed and revised as needed.
• Performs/updates risk assessments in partnership with network and Quality counterparts.
• Coordinates and conducts start-up and troubleshooting activities.
• Execute equipment C&Q, write-up, and review using existing documentation and protocols.
• Collaborate with the companys Automation engineering team to coordinate control systems design, installation, and commissioning needed for the core processing systems.

Target Experience & Knowledge:

• Degree in Life Sciences or Engineering and 7 years experience,
• Biotech certificate from approved program.
• Prefer experience, knowledge working with Single Use Technologies or modular.

Knowledge, Skills and Abilities

• Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving investigations and theory.
• Ability to lead department and/or cross functional meetings or project.
• Comfortable working in an agile and ambiguous environment.
• Has demonstrated a commitment to quality.

Work Environment/Physical Demands/Safety Considerations:

• Work in office, manufacturing, and, to a lesser extent, laboratory environment.
• May be on feet for 4 to 5 hours a day.
• Able to work a flexible schedule to meet start-up activity requirements.
• Lifting up to 25lbs may be required.
• May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
• May work with hazardous materials and chemicals.
• Most of the time will work a standard Monday - Friday 8am - 5pm type of schedule
• There will be times where we need to work a shifted 12/12/12/4 Schedule during the technical run.
• Expected to last about 6 weeks. Sometime in August/September timeframe

The hiring range for this position is $40 to $47 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on the candidates geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.