Production Engineer, Validation and Development Quality

Posting Date 2 months ago(12/15/2017 8:24 AM)
Requisition ID
Job Location(s)
Indianapolis IN United States
Less than 10%
Shift Type
Position Type
Full Time
Cook Regentec LLC


The Production Engineer, Validation and Development Quality for Cook Regentec Inc. will process and equipment validations including the preparation of protocols and reports as well as tracking the implementation of required actions as a result of qualification/validation activities, be the owner of the site and product validation master plans and internal validation programs, identify gaps within the program, inclusive of program procedures and processes, develop plans to strengthen the program, and then follow through on successful and timely execution of the plan, develop or review and approve plans and protocols, execution of qualifications, and preparation of reports per internal procedures, regulatory expectations, and industry standards, execute validations on time, and be the site validation Subject Matter Expert (SME).


• Preparation and execution or review and approval of IOPQ’s for manufacturing and QC equipment, facility and spreadsheet qualifications
• Preparation of required manufacturing process and test method validation protocols and reports to support new product submissions
• Write and resolve validation deviations
• Prepare associated ancillary and/or support documents required for execution of validation documents including, but not limited to SOPs, Work Instructions, batch records, testing documents, spreadsheets, etc
• Ensure all executed protocols meet internal and cGMP requirements
• Preparation of required change control documentation to revise and implement ancillary documents (SOPs, Work Instructions, Forms, etc). Track documents through to implementation
• Support other site priorities as needed

• Owner of the validation master plan
• Owner of the site validation procedures
• Support site audits
• Work closely with development project leaders to ensure development plans and documents meet internal Quality Engineering expectations
• Represent CGBT and CBD quality units as a technical reviewer for production and development document reviews
• Perform developmental product inspection activities to ensure product manufacturing meets quality requirements
• Support or conduct of Supplier Quality Audits of new suppliers to determine adherence to acceptable quality requirements, standards, and regulations
• Assist with internal audits of the quality system to determine the effectiveness and dependability of the system
• Review and determine the acceptability of non-conformances and proposed corrective and preventive action plans for product
• Maintain current knowledge of FDA, ISO and industry requirements


• Bachelor’s degree in relevant science or engineering is required; Master’s degree in relevant science or engineering, a plus

• Experience with manufacturing process validation, test method validation and equipment qualification with excellent technical writing and communication skills.
• Able to work independently and possess good organizational skills as well as be able to handle multiple projects.
• 3-5 years validation experience in relevant industry (Biotech, Pharmaceutical, etc.) required.
• Six Sigma (DMAIC) Green Belt Certification, preferred


Physical Requirements:

• Must be able to sit and stand for long periods of time
• While performing the duties of this job, the employee is frequently required to walk, climb, balance, stoop, bend, kneel, crouch or crawl, and talk, hear, and smell. The employee is constantly required to stand/or sit, squat, turn/twist, reach, use hands to: finger, handle, feel or operate objects, tools or controls, and computer keyboards
• The employee must occasionally lift, carry, push or pull up to 50 pounds and/or frequently lift, carry, push or pull up

• Able to work in clean room environments
• Able to work in office space
• Strong interpersonal skills
• Must be able to perform work at both the Indianapolis and Bloomington locations when needed


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