Sr. Process Engineering Manager - Pharmaceutical / Medical Devices (295288)

Employment Type

: Full-Time

Industry

: Healthcare - Allied Health



Purpose:

This Senior Managerlevel position is responsible for overseeing all activities related todesigning and implementing manufacturing processes, and/or new equipment withinthe manufacturing environment. Positionhas oversight of all validation and verification activities in compliance withcGMP regulations. The role will haveresponsibility for the successful implementation of any new filling andpackaging processes within the manufacturing area. Engineers reporting to this Senior Managerwill work on various process improvement projects from packaging line upgradesto 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


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