Senior Validation Engineer

Posting Date 1 month ago(6/18/2021 4:29 PM)
Requisition ID
2021-9181
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
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 Senior Validation Engineer at Cook MyoSite is responsible for the successful planning and execution of qualification and validation work for routine support and for specific projects. This person will lead the Validation Engineers and ensure compliance with applicable site validation master plans and industry standards. The Senior Validation Engineer will oversee validation study designs and provide guidance and oversight to the executing engineer(s) as needed, including but not limited to protocol and summary report development, review, and approvals, quality system document authoring, resource planning, and representing the validation department in project planning meetings as the Subject Matter Expert (SME), as applicable.  The Senior Validation Engineer, in addition to acting as support for the other Validation Engineers, will also lead complex validation studies as the main SME and executor.

Responsibilities

• Responsible for site Qualification and Validation Master Plans that include, but are not limited to, manufacturing process validation, equipment qualification, utilities and facilities qualification, operator qualification, analytical instrument qualification, analytical methods validation, packaging and shipping qualification, and cleaning validation
• Serve as technical SME of validation and provide support during audits (both internal and external)
• Develop or improve processes for validation function
• Maintain consistent communication between Product Development (Process and Methods), Validation, Process Engineering, System/Process Owners, and QA
• Lead changes for validation department, manage change control activities and drive change to completion in timely and compliant manner
• Author, review and approve qualification and validation documents; provide direct technical expertise regarding validation requirements (E.g. Impact Assessments, URS, FAT, SAT, IQ, OQ, PQ, Summary Reports, RTM, PERs etc.)
• Provide guidance regarding protocol development and study design (E.g. statistical techniques)
• Contribute to and represent the validation function on cross functional teams for planning and execution purposes
• Manage compliance of validation activities with other departments to meet policies and industry standards
• Maintain current knowledge of FDA, EU and JP regulations, PDA and ISPE guidances and other industry standards
• Schedule validation activities and coordinate with other departments
• Review development/engineering reports and determine readiness for qualification or validation
• Ensure validation/qualification state is communicated to system owner and appropriate stakeholders
• Coordinate outsourced validation activities as applicable
• Communicate with validation manager on routine basis, update and discuss all validation related topics
• Escalate any validation related issues to validation manager in timely manner

Qualifications

• Master's degree in Engineering or the Life Science’s with 6 years direct relevant Validation experience or undergraduate degree in Engineering or the Life Science’s plus 8 years of direct, relevant Validation experience

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
• Ability to learn and support new systems and applications, and the ability to provide technical training to end users
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Proficiency or comfort level working with material of a highly technical or scientific nature

• Minimum of 8+ years' experience in Validation is preferred 
• ICH Q2, Q8, Q9 and Q10 understanding is preferred
• Knowledge of GEPs Knowledge of risk-based engineering methods and industry guidance documentation (i.e ISPE) is preferred

• Six Sigma and Lean manufacturing knowledge, certification preferred
• Robust understanding of regulations and guidelines governing biological product development and Validation, i.e. EU GMP annex 15, CFR 210 and 211, ATMP guideline, FDA process validation guideline is preferred

 

Physical Requirements:

• 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
• 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

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