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Manufacturing Engineer

Location
Hayward, CA

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As a key member of our Facilities, Maintenance and Engineering Team, the
Manufacturing Engineer
is responsible for providing engineering support for cGMP manufacturing operation related to either Spray Drying, Mixing or Filling/Finishing. The role is the technical expert within commercial manufacturing and will work closely with other technical functions in product development & process development. This role is operational, supporting production to ensure on time supply of the quality product needed by our patients. The Process/Senior Process Engineer will also ensure technical processes are maintained to be compliant with latest regulations. The Engineer will raise our overall performance through technical improvements, ensuring our validation status is always maintained.
Duties and Responsibilities:
Acts as technical expert to train and coach process technicians
Writes and reviews technical documentation (batch records, SOPs,)
Assesses any technical changes brought to the change control committee
Supports and Drives technical investigations
Ensures any new process is properly transferred and validated from development to commercial manufacturing
May perform hands-on activities in operations, ranging from setting equipment, inspection of parts and support to maintenance.
Ensures successful manufacturing production runs by assessing risk, establishing preventative measures, investigating and troubleshooting equipment issues
Qualifications:
A Bachelors degree in Engineering, Chemistry, Biology or equivalent
5 to 8 years of pharmaceutical manufacturing experience in a technical function
Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
Experience managing in a commercial pharmaceutical production environment
Spray Drying or aseptic processing with isolators experience is a plus
Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is required; process validation experience is a plus
Skills:
Demonstrated knowledge of pharmaceutical manufacturing of sterile products, aseptic processing, medical device manufacturing, and process development
Demonstrated ability to think critically and analytically; demonstrated troubleshooting and problem solving skills
Good interpersonal, follow up, and excellent verbal and written communication skills
Ability to function efficiently and independently in a fast-paced, changing environment
Strong team player aligned with Intarcia Corporate Values

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