Engineer 2, Upstream - MSAT - job 1 of 2

Position Overview

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

Job Description

What You’ll Do

• Conducts lab and pilot plant experiments
• Generates and coordinates execution sampling protocols
• Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
• Leads and supports technology transfer (TT) across multiple unit operation
• Coordinates, plans, and executes manufacturing process validation runs
• Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
• Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed
• Generates and executes process training and consults on topics related to manufacturing and process
• Leads technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and  continued process verification
• Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.
• Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab
• Interprets and utilizes new knowledge to promptly drive data-based decisions
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability,  reliability, yield and cost
• Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
• Other duties, as assigned

Knowledge and Skills

• Proficient knowledge in Design of Experience (DOE)
• Proficient knowledge in Statistical Process Control
• Effective communication, both written and oral
• Ability to effective present information to others
• Proficient project management skills
• Advanced problem-solving skills
• Ability to provide feedback to others, including leaders
• Ability to develop effective working relationships internally and externally
• Ability to adapt communication style to differing audiences and advise others on difficult matters

Basic Requirements

• Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or 
• Master’s degree with no prior experience
• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)
• Experience in contract manufacturing or interacting with contract manufacturers

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No YesWill work in environment operating a motor vehicle or Powered Industrial Truck. X No YesAbility to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No YesAbility to stand for prolonged periods of time. X No YesAbility to sit for prolonged periods of time. X No YesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers. X No YesAbility to operate machinery and/or power tools. X No YesAbility to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes