Validation Engineers III

Merck•Jaffrey, NH

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Position: Validation Engineers III Employer: EMD Millipore Corporation 400 Summit Drive Burlington, Massachusetts 01803 Job Site: 11 Prescott Road Jaffrey, New Hampshire 03452 Travel: 10% domestic travel and 5% international travel required Responsibilities: Design and lead intermediate to complex level equipment and process validation activities; Lead investigations on validation protocol discrepancies to identify the root causes; Lead change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards; Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification; Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials; Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in validated state; Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer's specification and functional requirements; Prepare, maintain, and review Validation documentation for DQ, FAT, IQ, QQ, PQ, and process qualification; Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment; and Consult with management, assessing customer requirements to select validation objectives and standards. Requirements & Qualifications: Employer requires a Master's degree in Engineering, Biology, Chemistry, Computer Science, or a closely related field and three (3) years of progressively more responsible work experience as a Validation Engineer or related occupation in the pharmaceutical or medical device industry. In addition, the employer requires the following: Demonstrated knowledge of computer system validation lifecycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience; Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in the Biotechnology industry gained through two (2) years of work experience; Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, BioTech, life sciences industries gained through two (2) years of work experience; Demonstrated ability collaborating with individuals at all levels and functions of the organization and with external customers on critical projects gained through three (3) years of work experience; and Demonstrated knowledge of data analysis methods, Software, and tools, such as Minitab gained through one (1) year of work experience. Alternatively, the employer will accept a Bachelor’s degree in Engineering, Biology, Chemistry, Computer Science, or a closely related field and five (5) years of progressively more responsible work experience as a Validation Engineer or related occupation in the pharmaceutical or medical device industry. In addition, the employer requires the following: Demonstrated knowledge of computer system validation lifecycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience; Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in the Biotechnology industry gained through two (2) years of work experience; Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, BioTech, life sciences industries gained through two (2) years of work experience; Demonstrated ability collaborating with individuals at all levels and functions of the organization and with external customers on critical projects gained through three (3) years of work experience; and Demonstrated knowledge of data analysis methods, Software, and tools, such as Minitab gained through one (1) year 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#296182) or apply online at https://careers.emdgroup.com Salary Range: one hundred ten thousand dollars to one hundred twenty thousand dollars per year. Compensation is based on experience, location, and other factors. We offer generous benefits packages: https://careers.emdgroup.com/us/en/benefits . What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Requirements

Employer requires a Master's degree in Engineering, Biology, Chemistry, Computer Science, or a closely related field and three (3) years of progressively more responsible work experience as a Validation Engineer or related occupation in the pharmaceutical or medical device industry.
Demonstrated knowledge of computer system validation lifecycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience
Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in the Biotechnology industry gained through two (2) years of work experience
Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, BioTech, life sciences industries gained through two (2) years of work experience
Demonstrated ability collaborating with individuals at all levels and functions of the organization and with external customers on critical projects gained through three (3) years of work experience
Demonstrated knowledge of data analysis methods, Software, and tools, such as Minitab gained through one (1) year of work experience.
Alternatively, the employer will accept a Bachelor’s degree in Engineering, Biology, Chemistry, Computer Science, or a closely related field and five (5) years of progressively more responsible work experience as a Validation Engineer or related occupation in the pharmaceutical or medical device industry.
Demonstrated knowledge of computer system validation lifecycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience
Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in the Biotechnology industry gained through two (2) years of work experience
Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, BioTech, life sciences industries gained through two (2) years of work experience
Demonstrated ability collaborating with individuals at all levels and functions of the organization and with external customers on critical projects gained through three (3) years of work experience
Demonstrated knowledge of data analysis methods, Software, and tools, such as Minitab gained through one (1) year of work experience.

Responsibilities

Design and lead intermediate to complex level equipment and process validation activities
Lead investigations on validation protocol discrepancies to identify the root causes
Lead change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards
Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification
Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials
Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in validated state
Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer's specification and functional requirements
Prepare, maintain, and review Validation documentation for DQ, FAT, IQ, QQ, PQ, and process qualification
Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment
Consult with management, assessing customer requirements to select validation objectives and standards