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Sr. Process Engineering Manager - Pharmaceutical/Medical Device

HRU Technical Resources Cleveland ,OH
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

Purpose:

This Senior Manager level position is responsible for overseeing all activities related to designing and implementing manufacturing processes, and/or new equipment within the manufacturing environment. Position has oversight of all validation and verification activities in compliance with cGMP regulations. The role will have responsibility for the successful implementation of any new filling and packaging processes within the manufacturing area. Engineers reporting to this Senior Manager will work on various process improvement projects from packaging line upgrades to equipment/systems related to new product launches.

 

Essential Functions:

Manage and direct individuals assigned to process driven initiatives related to packing and filling products

Ensures all process engineering work is in complete with FDA requirements and follows Good manufacturing Practices and International Organization for Standards requirements

Mentors team of Process Engineers

Manage and guide efforts towards on-time design and execution of Process Validation Requirements

Ensure ECR/ECO process is understood and followed for all Engineering Changes

Audit Compliance

Works closely with Quality and Regulatory groups to ensure all Engineering and process Changes are compliant with Quality Management System

Develop implement improved validation policies

Work closely with manufacturing and engineering personnel to develop and maintain the required preventative maintenance plans for all equipment

Prepare, review, and approve process and packaging validation protocolors and reports

 

Education:

Bachelors Degree in Mechanical or Bio-Medical Engineering or other related discipline

 

Background:

10-15 years of reliated experience in the medical device or pharmaceutical industry

5-7 years experience leading an Engineering Process Improvement/Validation team in an FDA environment

Strong knowledge of GMP, FDA, and ISO requirements

Background in writing and performing Installation Qualification, Operation Qualification, and Performance Qualification protocols and documents

 

Company Description
HRU Technical Resources is a Technical Recruiting and Staffing Company. For 39 years we have helped clients and candidates nationwide in a variety of industries (Automotive, Military/Aerospace, Insurance, Education etc.) and professions; specializing in Engineering, IT, Supervisory and Technical related placements. However, we are able to place just about any skill set/job title, just about anywhere.

HRU Technical Resources

HRU Technical Resources is a Technical Recruiting and Staffing Company. For 39 years we have helped clients and candidates nationwide in a variety of industries (Automotive, Military/Aerospace, Insurance, Education etc.) and professions; specializing in Engineering, IT, Supervisory and Technical related placements. However, we are able to place just about any skill set/job title, just about anywhere.

Address

Cleveland, OH
USA

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