Validation Engineer

Join to apply for the Validation Engineer role at Sebela Pharmaceuticals Inc.

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market‑leading position in Gastroenterology and a focus on innovation in Women’s Health. Our vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women’s Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, operates its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical‑development and in‑house manufacturing services for specialty gastroenterology products.

We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland.

• Manage qualification and validation projects from planning stages to completion.
• Create and execute Equipment Qualification Protocols (IQ/OQ/PQ).
• Create and execute cleaning and process validation protocols.
• Create and execute Computerized Systems validation protocols.
• Responsible for the development of documentation to support computer validation such as User/Functional Requirements specifications, Design Specifications and Risk Assessments.
• Troubleshoot validation issues to maintain the quality of the product and maximize efficiency.
• Support establishing resolutions and impact assessment for validation issues.
• Perform batch record and SOP revisions.
• Draft Incident and Deviation reports.
• Complete cGMP documentation and validation protocols accurately.

• Bachelor’s degree or higher in Engineering, Life Sciences or related discipline.
• 3+ years relevant FDA regulated industry/validation experience or an equivalent amount of validation experience.
• Solid experience supporting/driving qualification and validation projects related to the pharmaceutical industry.
• Exceptional technical writing, review and analytical skills.
• Knowledge of good documentation practices and cGMPs.
• Must have strong ability to organize and manage multiple tasks in a fast‑paced environment.
• Exceptional verbal and written communication skills.
• AutoCAD experience preferred.

Pay Range: $33.00 - $43.00 per hour (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.

Seniority level:
Associate.

Employment type:

Full‑time. Job function:
Manufacturing. Industries:
Pharmaceutical Manufacturing.