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US-MA-Cambridge: QA Validation Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 14-Aug-2008
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Sr. QA Validation Engineer
POSITION SUMMARY
Position for the validation of clinical and commercial manufacturing equipment, support utilities, automation and computerized systems. This is a QA Validation Lead position that will include supervisory responsibilities for internal and / or contractual employees. This position description/summary reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.
POSITION DUTIES AND RESPONSIBILITIES
Protocol Generation - Generation and execution of qualification protocols and generation of final reports with no supervision.
Execution - Performs execution of protocols, review of executed protocols and final reports for other validation staff.
Trains and mentors junior members of validation team.
Responsible for mid size validation projects and oversight internal staff along with outside contractors.
Authority to approve departmental protocols and reports at discretion of Dept Manager.
Attend meetings/evaluate change controls for Validation Impact Assessments. Signature authority for Change Controls.
Oversight of Validation activities for manufacturing line/area/facility.
Attendance to all Operations Meetings.
Includes responsibility for qualification and Requalification activities.
Supervise internal and external staff.
Signature authority for P&ID’s at discretion of manager.
Guideline generation and/or review.
Signature authority for review of Work Orders and Metrology data sheets at discretion of Manager.
Minimum Education & Experience Requirements:
Education: BS degree preferable in Engineering or Science (equivalent)
Experience: 6+ years experience in cGMP pharmaceutical manufacturing environment. 7+ years experience without a degree.
Supervisory Experience: 1+ years
For more information, please write to us.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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