Process Engineer

Posting Date 2 weeks ago(9/14/2020 1:03 PM)
Requisition ID
2020-7873
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Production/MFG/Operations

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 Technical Services Process Engineer at Cook MyoSite is responsible for the maintenance and monitoring of the GMP manufacturing process from initiation to the filling and cryopreservation of the final product.   

 

Responsibilities

• Serve as the bridge between Product Development activities and GMP manufacturing implementation
• Integrate Product Development specifications and process requirements into the GMP manufacturing process by utilizing quality risk management in the design and evaluation of process changes. 

• Create and revise process related documentation

• Maintain all process related documentation including, Process Batch Records, Standard Operating Procedures, Work Instructions, Job Aids, and Forms.

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

• Monitor process data to ensure the process is stable and in a state of control and identify trends in data and the root cause of the trend in order to reestablish process control.
• Investigate deviations associated with the GMP manufacturing process. 

• Assist other departments with investigation writing, specifically the assessment of product impact.

• Implement CAPAs stemming from investigation or an observed trend and ensure the CAPAs efficacy and corrects/prevents future deviation.

• Manage and maintain the GMP manufacturing process

• Process Engineers are responsible for all changes that impact the GMP manufacturing process. 

• Ensure the following when changes to the GMP manufacturing process are proposed: justification in support of the proposed change, implementation of the change in accordance with the Cook MyoSite Quality System, collaboration with departments impacted by the change and accuracy and integrity of scientific work performed in support of the change.

Qualifications

• Undergraduate degree in any Life Sciences or Engineering or 6 years direct, relevant experience in engineering role within the biopharmaceutical industry to provide a comparable background

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

• Ability to work in collaborative and independent work situations and environments with minimal supervision

• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability 

• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals

• Must have effective verbal, written and interpersonal skills

• Able to prioritize and operate proactively

• Able to analyze situations or data

• 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.

 

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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