What are the responsibilities and job description for the Validation Engineer position at L&T Technology Services?
We are seeking an experienced Quality Validation Engineer to support equipment transfer and Business Continuity Planning (BCP) initiatives within a regulated medical device manufacturing environment. The ideal candidate will have strong hands-on experience in equipment qualification, process validation, and IQ/OQ/PQ protocol development and execution.
Key Responsibilities
- Lead equipment validation and qualification activities associated with manufacturing equipment transfers and relocations.
- Develop, execute, and close out IQ/OQ/PQ protocols and validation documentation.
- Perform process validation and equipment requalification to ensure production readiness.
- Conduct Gauge R&R and Measurement System Analysis (MSA).
- Validate manufacturing machinery, gauges, laser equipment, benches, workstations, and other production assets.
- Support equipment relocation, production line transfers, site transfers, and BCP initiatives.
- Troubleshoot validation issues, investigate deviations, and support corrective actions.
- Ensure compliance with applicable FDA regulations, quality standards, and medical device manufacturing requirements.
- Collaborate with Quality, Manufacturing, and Engineering teams to meet project timelines.
- Maintain accurate validation records and support audit and inspection readiness.
Required Qualifications
- 5 years of experience in Quality Engineering or Validation Engineering.
- Hands-on experience with equipment validation and qualification.
- Strong experience developing and executing IQ/OQ/PQ protocols.
- Experience in process validation and Gauge R&R.
- Proficiency in validation documentation, execution, and closeout.
- Ability to independently manage validation activities with minimal supervision.
- Strong troubleshooting, problem-solving, and cross-functional collaboration skills.
- Willingness to work fully onsite in Danvers, MA.
Preferred Qualifications
- Medical device or pharmaceutical manufacturing experience.
- Experience with J&J, Abiomed, or similar regulated manufacturing environments.
- Experience supporting equipment relocation, manufacturing transfers, or production line transfers.
- Familiarity with Business Continuity Planning (BCP) initiatives.
- Experience in FDA remediation or inspection-readiness environments.
Salary : $45 - $49