Sr. Manufacturing Validation Engineer (1 of 2)
Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Sr. Manufacturing Validation Engineer located in Danvers, MA.
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
Abiomed is seeking a highly skilled and experienced Senior Manufacturing Validation Engineer to join our dynamic team at our headquarters in Danvers, MA. As a Senior Manufacturing Validation Engineer, you will play a crucial role in ensuring the quality, compliance, and efficiency of our manufacturing processes, specifically focusing on validation activities. You will work closely with cross-functional teams to develop and implement robust validation strategies and ensure compliance with regulatory requirements.
- Develop and execute validation strategies, protocols, and reports for manufacturing processes, equipment, and systems to ensure compliance with FDA, ISO, and other relevant regulatory standards.
- Lead and oversee the execution of validation activities, including process and equipment qualification, cleaning validation, and software validation.
- Collaborate with internal stakeholders, including R&D, Quality Assurance, and Operations, to ensure alignment on validation requirements and deliverables.
- Conduct risk assessments and apply statistical methods to evaluate process capability, identify areas for improvement, and drive process optimization initiatives.
- Lead investigations into process deviations and non-conformances, perform root cause analysis, and implement corrective and preventive actions (CAPAs) as necessary.
- Provide technical guidance and mentorship to junior engineers, supporting their professional growth and development.
- Stay updated with industry best practices, regulatory guidelines, and technological advancements relevant to manufacturing validation, and proactively incorporate them into Abiomed's practices.
- Collaborate with cross-functional teams to support new product introductions and process transfers, ensuring robust validation plans are in place.
- Bachelor's degree in Engineering or related field; advanced degree preferred.
- Minimum of 7 years of experience in manufacturing validation within the medical device or pharmaceutical industry.
- Strong knowledge of FDA regulations, ISO standards (e.g., ISO 13485), and other relevant regulatory requirements.
- Experience with the validation of manufacturing processes, equipment, cleaning, and software systems.
- Proficiency in statistical analysis tools and techniques for process capability assessment and data analysis (e.g., Minitab).
- Proven track record of successfully leading and executing validation projects from start to finish.
- Excellent problem-solving skills and ability to conduct thorough root cause analysis.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented mindset with a focus on quality and compliance.
- Prior experience in cardiovascular or medical device manufacturing is a plus.
Join Abiomed's dedicated team and make a significant impact on the lives of patients in need. Apply your expertise in manufacturing validation to help us advance our life-saving technologies and shape the future of cardiovascular medicine.
Note: This job description is intended to convey information essential to understanding the scope of the Senior Manufacturing Validation Engineer role at Abiomed. It is not exhaustive and may be subject to change or modification based on the company's needs.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.