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Position: Validation Engineers III
Employer: EMD Millipore Corporation
400 Summit Drive
Burlington, Massachusetts 01803
Job Site: 11 Prescott Road
Jaffrey, New Hampshire 03452
Responsibilities:
The Validation Engineer III will apply comprehensive working knowledge of GMPs (Good Manufacturing Practices), GLPs (Good Laboratory Practices), GAMP (Good Automated Manufacturing Practices) and Part 11 compliance as they relate to qualification of systems in support of validation of processes. Specific duties include:
Creating and implementing standardized manufacturing processes to maintain operational efficiency and reliability;Troubleshooting and resolving issues encountered during field tests;Authoring documents pertaining to standard operating procedures, impact assessments, and final reports regarding validating processes;Performing deviation investigations, troubleshooting issues encountered during field execution activities, and generating deviation reports as required;Promoting and integrating cGMP (Current Good Manufacturing Practices; enforced by the U.S. Food and Drug Administration) regulatory compliance and quality by design (QbD) approaches into assigned projects;Generating and reviewing equipment specifications, owner project requirements, specifications, checklists and test data; andManaging project documentation such as protocols, reports, calibration certificates, and process trends.
Requirements & Qualifications:
Employer requires a bachelor’s degree in mechanical engineering, industrial engineering, or a closely related field and five (5) years of progressively more responsible work experience as a quality engineer, validation engineer, industrial engineer, or similar occupation responsible for adhering to cGMP or ISO requirements. In addition, employer requires:
Demonstrated ability performing process optimization for production or assembly lines and ensuring proper documentation at each stage of the process validation lifecycle gained through four (4) years of work experience;Demonstrated ability performing data collection and sampling and utilizing Minitab and MS Excel to analyze data and implement data driven solutions gained through four (4) years of work experience; Demonstrated ability writing and executing IQ, OQ, and PQ protocols and user requirement specifications gained though four (4) years of work experience; Demonstrated ability writing protocols for PLCs and performing testing, troubleshooting, and qualification of automated and computerized systems gained through four (4) years of work experience;Demonstrated ability performing project management and acting as a team lead within a cross-functional environment gained through four (4) years of work experience; and Demonstrated ability performing temperature mapping and validating laboratory, manufacturing, and facilities equipment gained through four (4) years of work experience.
In the alternative, employer would accept a master’s degree in mechanical engineering, industrial engineering, or a closely related field and three (3) years of work experience as a quality engineer, validation engineer, industrial engineer, or similar occupation responsible for adhering to cGMP or ISO requirements. In addition, employer requires:
Demonstrated ability performing process optimization for production or assembly lines and ensuring proper documentation at each stage of the process validation lifecycle gained through two (2) years of work experience;Demonstrated ability performing data collection and sampling and utilizing Minitab and MS Excel to analyze data and implement data driven solutions gained through two (2) years of work experience; Demonstrated ability writing and executing IQ, OQ, and PQ protocols and user requirement specifications gained though two (2) years of work experience;Demonstrated ability writing protocols for PLCs and performing testing, troubleshooting, and qualification of automated and computerized systems gained through two (2) years of work experience; Demonstrated ability performing project management and acting as a team lead within a cross-functional environment gained through two (2) years of work experience; and Demonstrated ability performing temperature mapping and validating laboratory, manufacturing, and facilities equipment gained through two (2) years of work experience.
All years of experience may be gained concurrently.
This position is eligible for EMD Millipore Corporation’s Employee Referral Program.
Applicants can send resumes to EMD Millipore Corporation, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req#283219 ) or apply online at https://careers.emdgroup.com
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