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Manufacturing Technical Specialist

3 months ago

Oceanside, California, United States MyKelly Full time

Pay rate: $30- $76 per hour based on experience.
Contract Length: 9 months
Location: Oceanside, CA

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

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 completionPrimary Responsibilities: Reviews & approves validation documents and protocols 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 our 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' work experience in the pharmaceutical or related industry 10 or more years' direct or indirect people and team management experience 5 or more years' work experience in a cGMP regulated environment, preferably in biologics manufacturing Prefer experience, knowledge working with Single Use Technologies or modular operationsSkills & 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 preferredWork 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#P