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Senior Validation Engineer
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34 Applications Submitted for this Position

Job Description

Job Title: Senior Validation Engineer (Process Validation)

Reports to: Validation and Metrology Supervisor

Industry: Pharmaceutical

Location: Greenville, SC

Status of hire: full-time, direct hire, salaried

Compensation: $90-105k plus bonus

 

Overview

The Sr. Validation Engineer (Process Validation) will be subject matter expert and provide leadership in validation of products and components at the Greenville site. In addition, the Sr. Validation Engineer (Process Validation) will lead the Media Fill program (execution schedule and investigations). The Sr. Validation Engineer (Process Validation) shall be able to manage consultants and mentor validation engineers and validation technicians. The Sr. Validation Engineer (Process Validation) will serve as a backup of the Validation Supervisor, mentoring co-workers, approving protocols, and managing consultants among others.

 

Responsibilities

·        Remain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices.

·        Provide validation requirements, strategy, protocols, execution and final reports for changes impacting validated products and critical process parameters.

·        Oversight of validation activities for R&D trials and new products.

·        Support engineering testing/trials and requirements for final product changes.

·        Creation, review, and update of risk analysis for changes and new processes that impact products.

·        Perform statistical analysis related to process validation.

·        Conduct periodic review of validated processes and equipment.

·        Support product annual product review.

·        Peer review validation studies executed by other validation team members.   

·        Provide inputs in validation and regulatory requirement for current direct impact equipment, new equipment, and processes.

·        Able to self-train in new regulation and industry standards

·        Demonstrate enough knowledge in basic validation skills and the ability to lead change control, approve quality changes request, and other discipline protocols in lieu of the Validation Supervisor, as needed.

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Job Requirements

Qualifications

Must have experience with FDA Process Validation Guidance, Statistical Sampling, Technical Writing, Use of MiniTab, and product validation

Must have a Bachelor’s of Science in Engineering or Science

Must have 8+ years Process Validation experience in Pharmaceutical, Medical Device or Parenterals

Must have experience in either an FDA or ISO Regulated Industry

Must have strong verbal and written communication; must be self-driven, and result oriented

Must have strong knowledge of process validation and intermediate statistics knowledge (sampling plans, hypothesis testing, etc.)

Must have background in use of PFEMA risk assessment or similar

Must have solution aseptic filling experience

 

*Would be helpful to have experience conducting and leading investigations, project management, Design of Experiments, and knowledge in aseptic simulation (media fills)

*Would be helpful to have demonstrated experience and proficiency with cGXP, ICH and PIC/S, and experience with regulatory and/or third party audits

 

**Must be able to pass a pre-employment drug test and background check to be eligible for hire

**Must be authorized to work in the US for any employer, regardless of sponsorship or visa transfer

Job Snapshot

Employment Type Full-Time
Job Type QA - Quality Control, Engineering, Manufacturing
Education 4 Year Degree
Experience At least 5 year(s)
Manages Others Not Specified
Industry Pharmaceutical, Manufacturing
Required Travel Negligible
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Senior Validation Engineer


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