This position will be responsible for maintaining validated state of site Equipment, to include Facilities, Manufacturing, and Automation systems. The candidate must be well organized and technically sound in understanding of Mechanical, Electrical, Automation and computer system validation principles.
- Serve as the site subject matter expert for Equipment, and automation validation.
- Generation and execution of Equipment, Automation and computer system validation protocols including the generation, routing and approval of summary documentation.
- Assess current manufacturing processes, equipment, tooling to identify and execute improvement opportunities.
- Assist in identifying, analyzing, and correcting manufacturing issues for process optimization.
- Work with cross functional teams during the entire process life cycle and provide technical assistance and training as a subject matter expert.
- Coordinate validation activities with plant support groups (Operations, Maintenance, Technical Services, Quality, etc.) for timely protocol executions.
- Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as necessary.
- Coordinate and execute validation studies (IQ, OQ, PQ FAT etc): writing protocols, analyzing and documenting results, and generate final summary reports. Validation activities include but not limited to equipment/system qualification, packaging process validation, cleaning/ sanitization validation, and computer related systems validation.
- Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical), Computer Science, or life science (Biology, Chemistry).
- Minimum 5-7 years of experience in a Validation or Quality Assurance role for medical device or pharmaceutical environment with specializing in utility systems, process equipment, automation and/or computer system validation. Validation project lead experience preferred.
- Experience with ensuring protocols, records and compliance with 21 CFR 11, 210, 211, & 820 and current Good Manufacturing Practices (cGMP).
- Computer knowledge of GAMP, 21 CFR Part 11 and other applicable computer system validation guidance or regulations.
- Ability to validate computer systems including the following features: electronic records, electronic signatures, audit trail, access security, back up/disaster recovery, data acquisition and reports etc.
Job Type: Full-time
- Validation or Quality Assurance: 5 years (Preferred)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Flexible schedule
- Parental leave
- Relocation assistance
- Professional development assistance
- Tuition reimbursement