Validation Engineer

MilliporeSigma; Danvers (MA); Hybrid; USD 100,000 - 200,000; Full time

Job summary

A leading company in the biopharma industry is seeking a Validation Quality Engineer for a 6-month contract in Danvers, MA. This hybrid role requires a degree in engineering and at least 3 years of validation experience. The engineer will develop and execute validation projects, ensuring compliance with quality standards while collaborating with cross-functional teams. Ideal candidates will possess strong communication skills and a solid understanding of quality engineering methodologies.

Qualifications

• 5+ years validation experience in biopharma, biotech, or medical device industries.
• Full understanding of product, equipment, and process validation.
• Hands-on experience in troubleshooting and quality system standards.

Responsibilities

• Develop and execute equipment and process validation projects.
• Lead execution of Quality Deliverables and Risk Management deliverables.
• Coach and mentor new and junior team members.

Skills

Communication

Teamwork

Problem Solving

Education

B.S. degree in Mechanical Engineering

B.S. degree in Electrical Engineering

B.S. degree in Biomedical Engineering

B.S. degree in Chemical Engineering

B.S. degree in Biochemistry

Tools

GMP

GCP

GLP

GAMP

ISO

FDA

Job description

Direct message the job poster from MilliporeSigma

Validation Quality Engineer

6 month contract

Candidates must have degree in engineering

Hybrid role in Danvers MA (3 days onsite per week)

Must have 3 plus years experience as a validation engineer in biopharma, biotech or medical devise industry

A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

Your role:

You will be in responsible for developing and executing equipment and process validation projects with a quality focus and risk-based approach. You will interact on a daily basis and develop strong relationships with Operations, Quality, Process Engineering, Planning, and other key internal/external stakeholders ( R&D, Supply Chain, etc.). Experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. Develop, establish, and maintain quality engineering methodologies, systems, and practices which meet Milliporesigma, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site and divisional quality goals and priorities.

Responsible for design transfer validation of New Product Introduction (NPI) to manufacturing at MilliporeSigma Danvers, MA site.

Primary Responsibilities:

• Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives.
• Driving cost reduction projects and reviewing/analyzing/improving the effectiveness of quality improvement tools and programs
• Leads the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Application Validation Plans.
• Leads the execution of Risk Management deliverables to ensure compliance to ISO 9001 and demonstrates a primary commitment to patient safety.
• Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, customer complaint investigations, and CAPA’s.
• Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls for product validation, process validation, and applicable validation activities.
• Manage project schedules with strict adherence to critical milestones to ensure quality and security of supply to EMD Millipore customers.
• Coach and mentor new and junior members of the team.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Lead in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validation
• Proactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance events
• Lead product risk assessment activities through application of a working knowledge of applicable standards and tools such as (application, design, process) FMEAs and FTA.
• Lead process validation by generating Validation Master Plan (VMP), IQ, OQ and PQ protocols and reports.
• Executing/supporting material qualification projects and leading/assisting with investigations related to raw materials/components.
• Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls (CTQ, CQA, CPP) for product validation, process validation, and applicable validation activities.
• Review the Change Control system to determine the impact of proposed changes to the qualification status of equipment and processes.
• Generate CTQ monitoring data for equipment and processes.
• Performing root cause analysis and corrective actions for process and equipment-related quality issues
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.
• Supports internal and external regulatory audits.
• Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes.
• Support development, implementation, and training of site quality initiatives.

Who you are:

Basic Qualifications:

• 5+ years validation experience handling of multiple projects within the biopharma, biotech or medical device industries.
• Minimum B.S. degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Biochemistry or equivalent
• Full understanding of product, equipment and process validation
• Demonstrated capability of applying risk management concepts and tools
• Hands-on experience in troubleshooting and the application of quality system standards
• Experienced at working in cross-functional teams
• Strong written and verbal communication skills (internal/external)
• Strong teamwork and collaboration skills
• Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
• Experienced with Quality & GxP IT compliance requirements

Preferred Qualifications:

• ASQ Quality Engineer Certification (CQE)
• Six Sigma Certification
• Quality by Design
• Detailed Knowledge of GMP, ISO and FDA design and development quality requirements
• Knowledge of aseptic processing

MilliporeSigma 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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual made a good faith report of discrimination.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

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