Manufacturing Specialist

Role Summary

Manufacturing Specialist providing technical support to GMP manufacturing operations (i.e., Cell Culture, Purification, Media/Buffer) and staff. You will write and revise supporting documentation, perform training, implement new/improved procedures, materials, and equipment. Location: Brooklyn Park, MN.

Responsibilities

• Lead and support continuous improvement efforts to streamline the manufacturing process, reduce waste, maximize safety, and improve process yield, efficiency, and compliance.
• Conduct and document detailed investigations, track exceptional events, change proposals, and audit responses.
• Lead, participate, and/or collaborate with cross-functional teams to determine root causes, implement corrective/preventive actions related to equipment, process, and compliance, including facility support and external vendors.
• Contribute to implementation of new equipment, systems, and procedures; assess impact of new regulatory guidelines on current practice; initiate document change proposals; assist with training and auditing as appropriate.
• Analyze and trend data to aid in the development and/or revision of department processes and procedures.
• Analyze technical problems to contribute to development of new or modified processes involving manufacturing operations.
• Participate in special projects as necessary; serve as manufacturing liaison to other departments and sites.
• Complete mandatory training within required timeframe.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in Science or Engineering and 3+ years of experience in a GMP environment; or Associate degree in Science or Engineering and 5+ years of experience in a GMP environment; or High school diploma or GED and 7+ years of experience in a GMP environment.
• Demonstrated application of current Good Manufacturing Practices (CGMPs) and Good Documentation Practice (GDP).
• Advanced scientific understanding of biology/microbiology and chemistry/biochemistry and strong technical understanding of how they apply to the manufacturing process.
• Proficient and knowledgeable in the operation and complex troubleshooting in the primary area of responsibility (i.e., downstream, upstream, media buffer).
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA and/or Materials Management and ability to work cross-functionally with these areas.
• Strong technical knowledge of manufacturing equipment operation, maintenance, and changeover; as well as commissioning, validation, and troubleshooting.
• May have more specific skill sets in areas depending on need/opportunity; aseptic technique, clean room management, MES, column packing, bioreactor operation, chromatography, SAP, etc.
• Strong verbal and written communication skills.
• Knowledge of basic chemical and biological safety procedures.
• Must be team- and detail-oriented and able to work in a fast-paced environment.
• Computer skills, including PowerPoint, Word, Access, and Excel; proficiency in mathematics, word processing, technical writing, and spreadsheet management.
• Must have passion to innovate and drive for solutions.
• Must have excellent planning and organizational skills.

Additional Requirements

• Work in a controlled environment requiring gowning and wear protective clothing over the head, face, hands, feet and body, including PPE such as safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves, and hearing protection as required.
• Remove all makeup, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Required to stand/walk for several hours at a time while operating manufacturing/computer equipment.
• May be required to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials.
• May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in the work campus).
• May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
• May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
• Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
• May be required to perform visual inspection of production equipment, materials, and activities.
• May be required to perform occasional overhead reaching during handling of production materials/files/supplies.
• May be required to occasionally work off-shift hours to help support a 24-7 manufacturing department.
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily.
• On rare occasions, travel may be required to offsite meetings or training events.