Validation Engineer 4

New Marlborough, MA - USA

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

Validation Engineer 4
Marlborough MA - Onsite
6 Months
Day to day:

The Validation Engineer plans executes and documents validation activities to ensure that equipment processes methods software and systems used to manufacture and control in vitro diagnostic (IVD) medical devices are fit for their intended use and meet regulatory and quality system requirements. They will lead to the validation of legacy manufacturing processes and equipment ensuring validated processes effectively control CTQs derived from ISO 14971 Risk Management documentation and applicable product specifications. This role supports compliance with ISO 13485 ISO 14971 EU IVDR (EU) 2017/746 FDA 21 CFR 820 and internal procedures through development and maintenance of robust validation protocols reports and lifecycle documentation.

Develop and maintain validation plans (e.g. Master Validation Plan) for manufacturing test methods equipment computerized systems and cleaning processes used for IVD products.
Define validation scope acceptance criteria sampling plans and risk-based rationales aligned with ISO 14971.
Develop and execute process validation protocols including IQ/OQ/PQ for new and legacy manufacturing processes and equipment; determine validation or re validation requirements as needed.
Develop and execute Test Method Validation (TMV) and method validation/verification protocols (e.g. analytical functional diagnostic methods) in line with relevant standards and guidance (e.g. CLSI ISO 15189 where applicable).
Perform Measurement System Analysis (MSA) and statistical evaluation of test method capability process capability and method robustness.
Conduct software/computerized system validation (CSV) for GxP relevant systems in accordance with regulatory expectations (e.g. GAMP 5).
Coordinate and perform validation studies ensuring protocol adherence complete/accurate documentation and appropriate data collection and analysis.
Establish and maintain traceability between CTQs risk controls user requirements design outputs process parameters and validation acceptance criteria.
Collaborate with cross functional teams (e.g. Quality Manufacturing Engineering R&D QC Regulatory Affairs IT) to ensure validation strategies reflect PFMEA outputs process risks and regulatory expectations.
Support change control by assessing validation impact of design process equipment software or supplier changes and defining revalidation or verification requirements.
Prepare clear concise validation reports summarizing methods results deviations risk assessments and conclusions.
Provide validation and qualification expertise for cross functional projects including new product introductions and process transfers and train colleagues on validation principles documentation and regulatory expectations.
Excellence through Integrity Compliance Safety and Environment
Ensure compliance with all company policies and procedures including safety regulations Personal Protective Equipment (PPE) requirements Standard Operating Procedures (SOPs) Quality Management System regulation (QMSR) ISO standards and Good Documentation Practices (GDP).
Demonstrate a strong commitment to the companys core values including integrity respect collaboration and innovation.
Actively contributes to a positive and inclusive work environment supporting colleagues and promoting a culture of mutual respect and teamwork.
Participate in regular training and complete all training on time.

Required Skills:

Bachelors degree or masters degree in engineering (e.g. Biomedical Chemical Mechanical Industrial) or related discipline or equivalent combination of education and experience.
10 years of validation experience in the Medical Device industry or regulated manufacturing environments.
Hands-on experience with IQ/OQ/PQ method validation and computerized system validation.
Solid understanding of:

IVD / medical device regulations and standards (e.g. IVDR 21 CFR 820 ISO 13485 ISO 14971).
Validation principles (process equipment method software cleaning).
Risk management and design transfer concepts.
Statistical methods used in validation (e.g. capability analysis MSA sampling plans).
Strong technical writing skills for protocols reports and rationales.
Detail-oriented systematic and data-driven.
Strong technical writing problem-solving and analytical skills.
Ability to work independently manage multiple projects and meet deadlines in a regulated environment.

Validation Engineer 4 Marlborough MA - Onsite 6 Months Day to day: The Validation Engineer plans executes and documents validation activities to ensure that equipment processes methods software and systems used to manufacture and control in vitro diagnostic (IVD) medical devices are fit for their in...

Validation Engineer 4
Marlborough MA - Onsite
6 Months
Day to day:

Develop and maintain validation plans (e.g. Master Validation Plan) for manufacturing test methods equipment computerized systems and cleaning processes used for IVD products.
Define validation scope acceptance criteria sampling plans and risk-based rationales aligned with ISO 14971.
Develop and execute process validation protocols including IQ/OQ/PQ for new and legacy manufacturing processes and equipment; determine validation or re validation requirements as needed.
Develop and execute Test Method Validation (TMV) and method validation/verification protocols (e.g. analytical functional diagnostic methods) in line with relevant standards and guidance (e.g. CLSI ISO 15189 where applicable).
Perform Measurement System Analysis (MSA) and statistical evaluation of test method capability process capability and method robustness.
Conduct software/computerized system validation (CSV) for GxP relevant systems in accordance with regulatory expectations (e.g. GAMP 5).
Coordinate and perform validation studies ensuring protocol adherence complete/accurate documentation and appropriate data collection and analysis.
Establish and maintain traceability between CTQs risk controls user requirements design outputs process parameters and validation acceptance criteria.
Collaborate with cross functional teams (e.g. Quality Manufacturing Engineering R&D QC Regulatory Affairs IT) to ensure validation strategies reflect PFMEA outputs process risks and regulatory expectations.
Support change control by assessing validation impact of design process equipment software or supplier changes and defining revalidation or verification requirements.
Prepare clear concise validation reports summarizing methods results deviations risk assessments and conclusions.
Provide validation and qualification expertise for cross functional projects including new product introductions and process transfers and train colleagues on validation principles documentation and regulatory expectations.
Excellence through Integrity Compliance Safety and Environment
Ensure compliance with all company policies and procedures including safety regulations Personal Protective Equipment (PPE) requirements Standard Operating Procedures (SOPs) Quality Management System regulation (QMSR) ISO standards and Good Documentation Practices (GDP).
Demonstrate a strong commitment to the companys core values including integrity respect collaboration and innovation.
Actively contributes to a positive and inclusive work environment supporting colleagues and promoting a culture of mutual respect and teamwork.
Participate in regular training and complete all training on time.

Required Skills:

Bachelors degree or masters degree in engineering (e.g. Biomedical Chemical Mechanical Industrial) or related discipline or equivalent combination of education and experience.
10 years of validation experience in the Medical Device industry or regulated manufacturing environments.
Hands-on experience with IQ/OQ/PQ method validation and computerized system validation.
Solid understanding of:

IVD / medical device regulations and standards (e.g. IVDR 21 CFR 820 ISO 13485 ISO 14971).
Validation principles (process equipment method software cleaning).
Risk management and design transfer concepts.
Statistical methods used in validation (e.g. capability analysis MSA sampling plans).
Strong technical writing skills for protocols reports and rationales.
Detail-oriented systematic and data-driven.
Strong technical writing problem-solving and analytical skills.
Ability to work independently manage multiple projects and meet deadlines in a regulated environment.