Validation Engineer 3

Millipore Corporation; Peterborough (NH); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other perquisites

Job summary

Millipore Corporation seeks an experienced Validation Engineer III to perform complex validations of equipment, materials, and processes for high-purity manufacturing. You will lead qualification activities, assess risk, and collaborate across Manufacturing, Planning, and Quality Control to ensure CGMP compliance.

The role requires mentoring junior engineers, driving project plans, and delivering CQV documentation (DQ/IQ/OQ/PQ).

Qualifications

• Bachelor's degree in engineering, sciences, or related field with GMP exposure.
• 5+ years in FDA-regulated medical device or pharmaceutical manufacturing.
• Experience leading validation of automated and manual processes with ISO/good engineering practices.

Responsibilities

• Lead complex validations and qualifications of equipment, materials, and processes.
• Coordinate validation execution with Manufacturing, Planning and Quality Control.
• Prepare and review CQV documentation (DQ/IQ/OQ/PQ) and test results.
• Mentor team members and contractors on validation strategies and cycle development.
• Lead RCA and CAPA actions to prevent reoccurrence and improve processes.
• Represent Validation during internal and external audits.

Skills

Validation expertise

Cross-functional leadership

Quality systems

Regulatory compliance

Statistical analysis

Education

Bachelor's Degree in STEM

Master's Degree in STEM (preferred)

Tools

Minitab

CAD software

HMI/PLC

Job description

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The Validation Engineer III is an advanced level validation engineering position responsible for executing complex validations and qualifications of equipment, materials, processes and tests used in the production of high purity filters, prioritizing a focus on quality and safety. Responsible for establishing and maintaining qualification techniques. This position may lead lower-level engineers to ensure their projects meet validation standards. This role requires close collaboration with cross functional teams to assess risk, disposition product, resolve complex problems, and ensure projects and programs meet their expected objectives.

Duties Include

• Expert with Qualification and Validation of Manufacturing Equipment, QC equipment, raw materials, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and Performance qualifications (temperature mapping and process qualification).
• Drive validation requirements needed for advanced manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements.
• Coordinate the scheduling of validation execution by collaborating with Manufacturing, Planning and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
• Prepare, maintain, and review Validation documentation such as CQV documentation for DQ, FAT, IQ, OQ, PQ, and process qualification.
• Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment and GMP production.
• Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
• Represent the Validation department during internal and external audits.
• Brings solution recommendations to management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
• Provide guidance and mentorship to team members and contractors regarding cycle development and validation of complex manufacturing equipment and raw material changes.
• Proficient at developing complex project plans to drive process improvements or changes, and capable of leading a cross functional team to meet deadlines.
• Able to anticipate challenges and roadblocks, and experiments with alternative and innovative solutions to avoid just refining existing solutions.
• Highly skilled at building consensus with a cross functional team at all levels and converting vision into clear goals and milestones.
• Facilitates effective teamwork by actively managing team dynamics.
• Anticipates challenges by utilizing knowledge / history to prevent issues from occurring.
• Helps develop other experts by giving concrete advice, coaching, and mentoring on how to succeed in a business setting.
• Leads Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) actions, implementing robust solutions to address root cause and prevent events from reoccurring.
• Expert technical writing skills and strong understanding of Current Good Manufacturing Practices (cGMP).
• Proficient at leading complex equipment and process validations activities, including protocol and report writing, review and execution.
• Leads strategic or complex change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards.
• Anticipate roadblocks and challenges and navigate the team through problems to meet deadlines.

Physical Attributes

• Physical flexibility to interact with and troubleshoot machinery and equipment.
• Exposure to chemical reagents.
• Use hand and power tools.
• Sit, stand, and walk for extended periods of time.
• Frequent lifting/carrying of 26 - 50 lbs.
• Occasional lifting 75Lbs.
• Bend, squat, stoop, and kneel.
• Pinch, grasp, and manipulate objects consistently and regularly.
• Fine motor skills.

Minimum Qualifications

• Bachelor's Degree in STEM (engineering, sciences, or computer science, etc.), technical management, business management.
• 5+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry leading the validation of automated and manual assembly processes with working knowledge of ISO, cGMPs and Good Engineering Practices.

Preferred Qualifications

• Master of Science Degree in STEM (engineering, sciences, or computer science, etc.), technical management, or business management.
• Read and understand complex mechanical and electrical drawings and P&ID's.
• Lean/Six Sigma experience, with a green or black belt certification.
• Experience with HMI/PLC and preferred code knowledge.
• Strong communication skills.
• Manage and lead multiple projects and participate on cross-functional project teams.
• Must be self-driven, able to work independently, and in teams with urgency.
• Proven ability to analyze complex data sets, apply statistical analysis principles, and clearly summarize conclusions/results.
• Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.
• Experience with Microsoft products, Minitab, and CAD software packages.
• Understand safe work practices and experience in lockout, tag out, electrical safety, etc.

Pay Range for this position: $105,000 -$115,000 annually

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.

• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites

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!