Validation Engineer

Syner-G is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.

(This list is not exhaustive and may be supplemented and changed as necessary.)

- Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification.

- Support validation activities for client projects, including generation, execution, review, and closure of validation life cycle documents

- Write, review, and revise Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.

- Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.

- Write procedures, investigations, protocols, reports, change controls, etc., to support the execution and closeout of validation work.

- Perform execution support activities including P&ID walkdowns, drawing reviews, and ETOP verification.

- Perform thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.

- Support the resolution of regulatory observations or manufacturing site issues.

- Execute periodic reviews and requalification for temperature chambers.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.