Validation Manager

Overview

Work Location:

Bedford, Massachusetts

Shift: No
Department: LS-PS-RVC Validation & Applications Center
Recruiter:
Stefanie Fried

As a Validation Manager in the R&D Validation & Applications Center (VAC), you lead engineers to validate new Aseptic, Virus clearance & clarification Filtration products. You effectively allocate and manage resources to ensure validation activities and deliverables are completed on time and meet high-quality standards. You guide your team in the development and validation of new test equipment and methods, providing technical consultation on validation topics to product development teams.

You understand when and how to leverage the flexibility within our product development processes appropriately. In addition to managing employee performance, you identify training and development opportunities to foster team growth. You offer leadership and strategic guidance to the VAC team, driving data-driven problem-solving and continuous improvement initiatives that impact both the VAC and product development teams. You effectively collaborate with R&D, Quality, Project Management, Product Management, Operations / Manufacturing, EHS and Facilities.

Minimum Qualifications:

• Bachelor’s degree in an Engineering field with 8-10+ years of experience in process development/validation
• 7+ years of experience with product/process/system validations (IQ/OQ/PQ)
• 7+ years of experience with FMEA/risk analysis, product failure and root cause analysis
• 5+ years of experience using statistical tools such as Gage R&R, DOE, capability analysis and data analysis in Minitab or equivalent

Preferred Qualifications:

• Leadership training and experience managing engineers and/or lab personnel including employee performance evaluations
• Cross functional work experience in product development, process development or validation
• Comprehensive understanding of quality principles including ISO, quality management systems, Good Documentation Practices
• Knowledge of FDA Regulations, USP requirements, and other regulatory and compendial requirements applicable to biomanufacturing process and equipment
• Understanding of new product development processes
• Proficient in equipment calibration, troubleshooting and repair
• Experience with capital equipment projects and equipment design, development, and upgrades
• Experience developing and executing test method validations
• Working knowledge of safety and ergonomics principles
• Experience with Millipore Sigma filtration, chromatography and Mobius products
• Experience with plastics processing
• Experience with change control methodology
• Formal management training
• ASQ – CQE Certification

Additional

This position may include occasional travel to our manufacturing facilities

This role must be based in the Bedford, MA site

Pay Range for this position: $114,700 - $219,500. 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 .

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.