Validation Engineers III

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Validation Engineers III at EMD Millipore Corporation, onsite in Jaffrey, New Hampshire, is a full-time role requiring either a Master’s degree in Engineering, Biology, Chemistry or Computer Science with three years of progressive validation work, or a Bachelor’s with five years. You will design and lead intermediate to complex validation activities for manufacturing and QC equipment and processes, drive investigations, manage change controls, CAPAs and deviations, and ensure GMP validation across equipment, facilities, utilities, and computer systems. Expect 10% domestic and 5% international travel; salary range $110k-$120k plus benefits. Apply by tailoring your resume to lifecycle validation, LIMS/PLC/HMI, clean-room releases, and data analysis, and submitting online at careers.emdgroup.com or sending to Attn Req#296182, 400 Summit Drive, Burlington MA 01803.

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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

Travel: 10% domestic travel and 5% international travel required

Responsibilities:

1. Design and lead intermediate to complex level equipment and process validation activities;
2. Lead investigations on validation protocol discrepancies to identify the root causes;
3. Lead change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards;
4. Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification;
5. Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials;
6. Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in validated state;
7. Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer's specification and functional requirements;
8. Prepare, maintain, and review Validation documentation for DQ, FAT, IQ, QQ, PQ, and process qualification;
9. Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment; and
10. 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:

1. Demonstrated knowledge of computer system validation lifecycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience;
2. 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;
3. Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, BioTech, life sciences industries gained through two (2) years of work experience;
4. 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
5. 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:

1. Demonstrated knowledge of computer system validation lifecycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience;
2. 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;
3. Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, BioTech, life sciences industries gained through two (2) years of work experience;
4. 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
5. 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.

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