Manufacturing Technical Specialist

6 months ago

Oceanside, United States Innova Solutions Full time

Innova Solutions is immediately hiring for Manufacturing Technical Specialist

Position type: Full time Contract
Duration: 10+ Months
Location: Oceanside, CA

As a Manufacturing Technical Specialist you will:

Description
Primary Responsibilities:

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 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 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. 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 prior to CQ execution on the assigned unit operations 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 CQ write-up and review using existing documentation and protocols. Collaborate with the 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 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 bull Bachelor's Degree required science or engineering is preferred bull 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 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 jewellery can be worn when working in the clean room environment. May work with hazardous materials and chemicals.

Thank you

PRATEEK GODSE
(+1) 425 -
()

PAY RANGE AND BENEFITS:
Pay Range*: $76- $81 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

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