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, has 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. We accomplish this 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.

The Validation Engineer is responsible for performing the necessary activities required to implement the Holbrook site's validation plan in compliance with current industry and regulatory expectations. This includes the creation and execution of Qualification and Validation documents and ensuing reports, and authoring cGMP documents.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• 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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in Equipment and Utility Qualification, Process Validation, Cleaning Validation and Computerized System Validation. The requirements listed below are representative of the knowledge, skills and/or abilities required.

• 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.
• Auto CAD experience strongly 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.