Senior Process Engineer

Posting Date 3 weeks ago(3/22/2021 9:07 AM)
Requisition ID
2021-8741
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Engineering

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Senior Process Engineer at Cook MyoSite directs and guides Process Engineering activities in a cGMP manufacturing environment. The Senior Process Engineer maintains and monitors manufacturing processes throughout the lifecycle of biologic cGMP products.

Responsibilities

• Maintain a solid understanding of the Cook MyoSite GMP manufacturing process, and utilize that understanding within projects, risk assessments, decision making, and audit support.

• Serve as technical SME of GMP manufacturing processes at Cook Myosite, provide feedback associated with internal or external queries and questions related to manufacturing process including audits.

• Provide oversite to Process Engineers, specifically related to projects and work associated with the GMP manufacturing process.

• Identify areas of improvements of GMP manufacturing process and related systems and champion the changes that takes processes towards better controls and focus on Quality by Design.

• Maintain control strategy of GMP manufacturing process and update as required.

• Develop trending strategy for GMP manufacturing processes and review and approve reports.

• Maintain continues communication between product development, quality assurance and production.

• Identify process optimization opportunities and implement engineering studies required for optimizations.

• Guide and train Process Engineers.

• Aid GMP manufacturing personnel in process related decisions that have the potential to impact product.  On-the-floor support may be required.

• Create and maintain all process related documentation including, Process Batch Records, Standard Operating Procedures, Work Instructions, Job Aids, and Forms.  Serves as the approver on all process related documentation.

• Investigate high level and trend investigations associated with the GMP manufacturing process.  Acts as the PE approver for investigations that require PE approval.

• Implement CAPAs stemming from investigations or an observed trend and ensure the CAPAs are effective and correct/prevent future deviations.  Utilize process knowledge to guide Process Engineers in the implementation of CAPAs, when necessary.

• Manage large changes that impact the GMP manufacturing process.

• Participate in risk assessment as Process Engineering representative and approve risk management documents.

• Lead risk mitigation activities required from process engineering for manufacturing processes and related systems.

• Lead technology transfer activities associated with the GMP manufacturing process.

• Serve as an approver for all documentation in place of the PE Manager, when required.

• Participate in steering committees or boards as the PE representative and a GMP manufacturing process SME.

• Report periodically on status of tasks to PE manager.

• Work with PE manager to develop departmental strategy.

Qualifications

• Undergraduate degree in Life Sciences or 8 years direct, relevant experience in Bio/Pharmaceutical product manufacturing to provide a comparable background
• Minimum of 8 years' experience within the biopharmaceutical or healthcare industry

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

• Proficient knowledge of Microsoft Office software, and other general office equipment.

• Project management experience or experience as part of a project team or project team leader.

• Understanding of risk management principles

• Process validation and continuous process monitoring experience preferred

• Control strategy, SOP and batch record documentation experience and skills

• Quality by Design principles

• Other preferred skills and experience includes: investigations writing, change management, Lean principles
 

Physical Requirements:

• Lab / Non-Production Setting: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.

• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

• Ability to work under specific time constraints.

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

• Visual and manual acuity for working with computers and equipment.

• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.

• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.

• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.

• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

 

 

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