Validation/Compliance Engineer

RESPONSIBILITIES

- Investigations- will be responsible for completing GO-initiated investigations
- Change Control- will be responsible for following up with responsible parties and ensuring that approved change controls are completed as specified.
- Vendor Management- will assist in the completion of vendor assessments (manage documentation related to vendor assessments)
- Validation- Will be required to utilize electronic document repositories to assist in the completion of ongoing validation activities including but not limited to: System/Equipment qualification; Periodic Review; SOP Updates; Completion of corrective/preventive quality tasks assigned

SKILLS

Must possess a BS or MS degree in one or more of the following disciplines: Engineering, Quality Management, or other scientific related discipline such as Chemistry, Physics, or facilities. A minimum of 3-5 years experience in validation, compliance, metrology, pharma manufacturing or other practical QA related field is required. A minimum of 5-7 years of practical experience with GxP regulated facilities or science equipment, or engineering experience in support of high-end R&D operations is needed. Must have at least 3 years of experience providing service in an engineering or maintenance capacity. Experience in Pharmaceutical R&D cGMP/cGLP and cGCP compliance needed. Must have MS Office skills. Experience in Quality Control and Biopharmaceutical environments needed. CMMS experience (4-7 years) required.

Synectics is an Equal Opportunity Employer.