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Job Description
To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepakarya8a79aa22a/ ), email your updated resume at Email deepak.arya@collabera.com . Thank you!
Pay Range:
$30 to $35 an hour.
Client Industry:
Medical Device Job Mode:
Onsite Contract Duration:
6 Months (Possible Extension- based on performance and business needs)
Job Summary:
We are seeking an experienced Validation Engineer to support validation and quality system activities within a regulated medical device and diagnostics environment. This role will be responsible for developing, executing, and maintaining validation documentation for equipment, facilities, laboratory systems, computerized systems, and manufacturing processes. The ideal candidate will have strong expertise in qualification activities, risk assessments, technical documentation, and regulatory compliance. The position requires collaboration with Quality, Engineering, Manufacturing, and Research and Development teams to ensure validated systems remain compliant and inspection ready. This is an excellent opportunity for professionals who thrive in a fast paced and highly regulated environment.
Key Responsibilities:
Develop and execute validation protocols, reports, investigations, CAPAs, deviations, and change controls. Prepare validation documentation including URS, FRS, DRS, DQ, FAT, IQ, OQ, PQ, PV, and engineering studies. Perform equipment qualification, process validation, facility qualification, and laboratory qualification activities. Execute computerized system validation and spreadsheet validation activities. Conduct risk assessments and validation impact evaluations. Analyze validation data and prepare technical reports. Support thermal mapping activities for temperature controlled environments. Maintain validation master plans and validation schedules. Ensure compliance with FDA regulations, ISO standards, GDP, and cGMP requirements. Support internal audits, external audits, and regulatory inspections. Manage validation related documentation within electronic document management systems. Collaborate with cross functional teams to resolve validation issues and drive continuous improvement initiatives.
Required Qualifications:
Bachelor degree in Engineering, Biology, Chemistry, or related scientific discipline. Minimum 5 years of validation experience within the medical device industry. Hands on experience with IQ, OQ, and PQ activities. Experience with process validation, equipment qualification, facility qualification, and laboratory qualification. Experience with computerized system validation and spreadsheet validation. Strong understanding of Design Control, GDP, and cGMP requirements. Knowledge of
FDA 21 CFR 820.30, FDA 21 CFR 820.70, FDA 21 CFR
Part 11, ISO 13485, and
ISO 14971.
Strong technical writing and documentation skills. Proficiency with Word and Excel.
Preferred Qualifications:
Experience validating In Vitro Diagnostic laboratory equipment. Experience with Real Time PCR systems, incubators, environmental chambers, freezers, and refrigerators. Experience performing thermal mapping studies. Experience supporting FDA inspections and
ISO 13485
audits. Knowledge of GAMP5 and Computer Software Assurance methodologies. Experience working in a multisite development environment. Lean Six Sigma or statistical analysis experience. Experience using Agile, Maximo, and ViewLinc systems.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)
