Validation Engineer

Responsibilities:
- Design required validation studies and write protocols for facility and equipment.
- Coordinate resources to complete validation studies on schedule.
- Execute validation studies safely and in compliance (e.g., LOTO).
- Analyze test data; report questions/issues.
- Lead and document investigations of failed validation test results.
- Complete validation protocols and validation summary reports with necessary approvals.
- Support review of new systems and modifications to ensure designs comply with cGMPs and can be validated and maintained in a validated state.
- Maintain validation equipment and supplies to enable completion per schedule.
- Support development of validation procedures and practices for the facility.
- Identify issues and/or improvements to validation procedures, practices, and policies.

Qualifications:
- Bachelor’s degree in a scientific discipline.
- OR 2+ years of experience working in a regulated GMP environment with an Associate degree.
- On-site role.

Preferred Qualifications:
- 1+ years of experience in Validation, Automation or Process engineering.
- Familiar with cGMPs.
- Strong interpersonal and organizational skills.
- Technical understanding of pharmaceutical industry validation practices.
- Strong verbal and written communication skills.
- Experience interacting with peers and senior personnel in multidisciplinary teams.
- Able to take directions and implement decisions effectively.
- Strong technical writing skills.