Process Engineer III

Job Description Summary

The Process Engineer III is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at a site.

The initial responsibilities for this role will be to support the design, build, and qualification of the equipment for a new large molecule drug substance facility. Upon project completion, the role will transition to engineering support and asset lifecycle management of the manufacturing equipment.

 

Job Description

Responsibilities:

 

• Ensures new equipment is appropriately designed/qualified and existing processes run in a compliant manner through equipment life cycle. Help define and optimize equipment qualification strategy.

• Owns and manages changes to the process equipment to maintain equipment in a validated state. Potentially take on a global role in ensuring consistency across manufacturing sites.

• Investigates any equipment or process deviations and developing corrective actions to prevent re-occurrences. Able to provide industry wide expertise for complex equipment and process investigations.

• Participates in all FDA and internal audits of the manufacturing facilities and process equipment as SME and responds to any observations received. 

• Develops and implements equipment reliability and maintenance strategies that are compliant, effective and cost appropriate.

• Applies knowledge of engineering principles and best practices to ensure robust solutions.

• Provides mentorship to other process engineers.

• Leads small internal teams to help optimize engineering systems and processes.

• Independently leads or provide SME support on capital related projects.

• Establishes equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).

• Works closely with operations and manufacturing sciences to evaluate new product introductions and facility fit evaluations.

• Leads small teams to define and advance facility and equipment changes in line with 5- and 10-year strategic plans.

• Leads evaluation of new technologies and equipment platforms for manufacturing.

• Provides engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at a site; equipment may include major processing equipment such as bioreactors, tangential flow filtration, chromatography, filling equipment, support systems such as incubators, freezers bio-safety cabinets, offline bench-top instruments or facility/utility systems. 

• Translates current and future processes into the facility and equipment requirements at a manufacturing site.

• Other related job duties as assigned.

 

Requirements:

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 5 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.

• Excellent oral and written communication skills. Strong technical writing ability required.

• Working in a team environment, with excellent communication and organizational skills.

• Diverse experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology.

• In-depth knowledge of FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.

• Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.

• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.

• Demonstrated ability to lead cross functional teams across manufacturing locations in a fast pace, dynamic team setting.

• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.

• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways

• Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

•  Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

•  Networks with senior internal and external personnel in own area of expertise.