Syner-G

Validation Engineer

Waltham, Massachusetts, United States

No sponsorshipDetected 14 days ago

VoIPGMPFDA RegulatoryMedical DevicesLeadershipCommunication

About the role

The Validation Engineer will play a key role in supporting operational readiness, tech transfer, and continuous improvement initiatives.

Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
Perform P&ID walkdowns to verify installation and system readiness.
Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
Perform periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor's degree in a life science, engineering, or related technical field.
Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.
Hands‑on validation experience in equipment, computerized systems (CSV), analytical methods, and process validation.
Experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
Strong verbal and written communication skills, with the ability to explain technical concepts to non‑technical stakeholders.
Ability to work independently and collaboratively in a fast‑paced, regulated environment.
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse
The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

A career here is life-enhancing.
Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Synergbiopharma.com

This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.

This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
Specific vision abilities required by this position include close vision and the ability to adjust focus.

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars.

LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

This listing is sourced directly from Syner-G's careers page and normalized into a canonical job model.