Senior Manufacturing Engineer - Contract - TalentBurst, Inc.

Position: Senior Manufacturing Engineer (Manufacturing Technical Specialist), Req#: ROCGJP00025482
Location: Oceanside, CA  (100% onsite)
Duration: 8 Months Contract (through the end of 2024, with potential extension based on the development and achievement of deliverables)

Job Description: 

The client founder of the biotechnology industry is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought, and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve.

Job Summary

The Manufacturing Technical Specialist position at the client site is the equivalent to and is a part of the engineering job family. This role would be equivalent to a Senior Engineer in our Manufacturing Sciences and Technology organization.

The Manufacturing Technical Specialist 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 that supports GMP production for phase 3 clinical trials and commercial products. The OSUT will employ a ballroom design, and 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. The 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 the South San Francisco Clinical Supply Center (CSC).

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 the initial cell bank thaw through the 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 a 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 were 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:

• Reviews & approves validation documents and protocols.
• Participates in safety assessments/reviews.
• Ensures necessary operating procedures are in place before 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 client’s Automation engineering team to coordinate control systems design, installation, and commissioning needed for the core processing systems.

Qualifications:

Target Experience & Knowledge:

• 15 or more years of work experience in the pharmaceutical or related industry
• 10 or more years of direct or indirect people and team management experience
• 5 or more years of work experience in a cGMP-regulated environment, preferably in biologics manufacturing

Prefer experience: knowledge of working with Single-Use Technologies or modular operations.

Skills & Competencies:

• Excellent verbal and written communication skills
• Excellent business acumen
• Ability to influence at all levels of an organization.
• Builds trustful and effective relationships.
• Thinks strategically and translates strategies into actionable plans.
• Takes responsibility, drives results, and achieves expected outcomes.
• Comfortable working in an agile and ambiguous environment
• Has demonstrated a commitment to quality.

• Bachelor's Degree required (science or engineering is preferred)
• Professional, Graduate, or higher-level degree is preferred.

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 a 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 a clean room environment.
• May work with hazardous materials and chemicals.
• Most of the time will work a standard Monday - Friday 8 am - 5 pm type of schedule.
• There will be times when we need to work a shifted 12/12/12/4 Schedule during the technical run. Expected to last about 6 weeks. Sometime in the August/September timeframe