Validation Engineers II

Job Title: Validation Engineers II

Employer: EMD Millipore Corporation, 400 Summit Drive, Burlington, MA 01803

Job Location: EMD Millipore Corporation, 11 Prescott Road, Jaffrey, NH 03452

Job Responsibilities:

1. Design and Lead intermediate to complex level equipment, and process validations 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 a 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, OQ, 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 and assess customer requirements to select validation objectives and standards.

10% domestic travel and 5% international travel is required.

Job Requirements:

Employer requires a bachelor’s degree in engineering, computer science, or a closely related STEM field, and two (2) years of work experience as a Validation Engineer, or related occupation, providing computer and equipment validation lifecycle experience.

In addition, employer requires:

1. Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in a startup Biotechnology industry gained through two (2) years of work experience;
2. Demonstrated knowledge of FDA 21 CFR Part 11 regulations gained through one (1) year of work experience;
3. Demonstrated knowledge of temperature mapping of controlled temperature units gained through one (1) year of work experience; and
4. Demonstrated ability performing Root Cause Analysis with robust Corrective and Preventive Actions in Life Science industry gained through one (1) year of work experience.

All years of experience may be gained concurrently.

This position is eligible for the EMD Millipore Corporation Employee Referral Program.

Applicants can mail resumes to EMD Millipore Corporation., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 291354 or apply online at https://www.emdgroup.com/en/careers/job-search.html)

Salary: One hundred three thousand to one hundred twenty-three thousand dollars per year.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.