Specialist Manufacturing: Manufacturing Execution System (MES)

What you will do

• Coordinate with Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records to support the implementation of new products and/or technologies into the plant.
• Lead and/or participate in projects to ensure that electronic batch records accurately and effectively record all necessary process data for unit operations in Koerber PAS|X.
• Support Manufacturing in troubleshooting, problem solving, and RCA's. Support CAPA development to prevent error recurrence.
• Own Generic Master Batch Record (GMBR) optimizations and function as the primary liaison between the site MES and global MES team to drive on-time deliveries of the GMBRs. Respond to regulatory questions and/or audit findings.
• Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant, and track progress on a plant level.
• Support batch record standardization to enable network-wide usage of generic batch records.

What we expect of you

• Bachelor's degree in chemistry, biology, or engineering with 5 years of biotechnology operations experience, or
• Masters degree in chemistry, biology, or engineering with 3 years of biotechnology operations experience, or
• Doctorate degree with relevant experience, or
• High school diploma/GED with 12 years of biotechnology operations experience.

Preferred qualifications include:

• A degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry,
• Excellent cross-functional project management, meeting facilitation, and technical writing skills,
• Experience in GMP manufacturing operations,
• Strong technical knowledge of drug substance processing (Inoculation, Bioreactors, Harvest, chromatography, filtration, buffer preparation), and a broad understanding of related disciplinary areas in bioprocessing,
• Extensive experience with electronic batch record design in Koerber PAS|X or comparable software for electronic batch records with some understanding of editing and validation,
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms,
• Ability to coach, mentor, and/or cross-train colleagues within core technical areas.

What you can expect of us

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements, where possible.