Validation Engineer
Posted on :
11-10-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1700679
Responsibilities:
- 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)
Employment Type
Full Time
Key Skills
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