Validation Engineer

Validation Engineer

Canton, MA (REMOTE AVAILABLE)

• Assist with develop and maintenance of Risk mitigation documents FMEA’s.
• Determine statistical technique to be used for determining effectiveness of design.
• Combination of equipment qualification, process validation, computer software validation, cleaning, and sterilization is favored.
• Write and execute protocols (IQ, OQ, PQ, etc) for various process, product, and equipment for internal and external requirements.
• Analyze and document test results, including report generation through release.
• Commissioning, qualification and validation of facilities, utilities, production, laboratory, and support equipment.
• Post validation surveillance.
• Establish validation standards, develop testing protocols, prepare equipment, document test results, and maintain records for later analysis.
• Ensure all systems are running correctly and efficiently to produce high-quality products.
• Interface with clients to interpret customer requirements.
• Write reports and adjust equipment or processes that require improvement.
• Investigate causes of equipment failure and identify equipment that needs to be repaired or entirely replaced.
• Recommend preventative maintenance, maintenance of testing equipment and oversee the inventory of validation supplies.
• Create and maintain log of all validation activities and schedules.
• Keep up to date on industry standards and regulations.

• Experience in Biotechnology and/or Medical Device manufacturing environment.
• Strong knowledge of cGMP (21 CFR 820), and ISO 13485 & 14971 quality system requirements.
• Experienced in biotechnology / medical device cGxP environment.
• Combination of equipment qualification, process validation, computer software validation, cleaning, and sterilization is favored.
• QA diagnostic / medical device experience is also preferred.
• Ideal candidates have strong working knowledge of molecular diagnostic and medical device product, facilities, equipment, and clean room facilities. Must be proficient with writing and executing protocols (IQ, OQ, PQ) and direct experience in the commissioning, qualification and validation of facilities, production, laboratory, and support equipment.
• Must have experience developing and maintaining effective FMEA’s, in support of Complaints CAPA’s, NCMR and Must have thorough working understanding of Industry guidelines, international regulations (cGMP, ISO: 13485, 14971, Statistical Analysis) for validation of GMP facilities.
• Experienced with EHS guidelines in a regulated manufacturing environment.
• Knowledge of Master Control EDMS (not required but appreciated)
• Knowledge of Bartender software (not required but appreciated)

Required Skills:

Write and execute protocols (IQ, OQ, PQ, etc) for various process, product, and equipment for internal and external requirements. Strong knowledge of cGMP (21 CFR 820), and ISO 13485 & 14971 quality system requirements. Validation Engineering experience equipment qualification, process validation, computer software validation, cleaning, and sterilization is favored.