CQV​/Validation Engineer

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 CQV/Validation Engineer is responsible for supporting the activities required to implement the Holbrook site's validation plan in compliance with current industry and regulatory expectations. This role supports the development, review, execution, and completion of qualification, validation, and related cGMP documentation.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Participate in validation, qualification, and commissioning activities for pharmaceutical manufacturing equipment, utilities, facilities, processes, cleaning programs, and computerized systems.
• Participate in validation and CQV projects from planning through documentation, execution, discrepancy resolution, approval, and closeout.
• Develop, review, and/or execute validation documentation such as change control, test scripts, protocols, reports, User Requirements Specifications, risk assessments, traceability matrices, and related supporting documents.
• Support equipment, utility, facility, process, cleaning, and computerized system validation activities, as assigned.
• Document and assist in resolving protocol discrepancies, deviations, incidents, nonconformances, and validation issues, including impact assessments and corrective actions/CAPA.
• Collaborate with Manufacturing, Engineering, Quality Assurance, Quality Control, Technical Operations, IT, and external vendors to support validation deliverables and project timelines.
• Review and revise GMP documentation, including SOPs, batch records, protocols, reports, forms, and related controlled documents.
• Complete GMP documentation and validation records accurately, clearly, and contemporaneously in accordance with company procedures and good documentation practices.

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 knowledge and experience in Equipment and Utility Qualification, Process Validation, Cleaning Validation and/or Computerized System Validation. The requirements listed below are representative of the knowledge, skills and/or abilities required. Equivalent combination of education and relevant experience will be considered.

• 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.
• Experience with validation, qualification, commissioning, CQV, manufacturing support, quality systems, engineering documentation, or technical project execution.
• Familiarity with one or more of the following areas is preferred: equipment qualification, facility qualification, utility qualification, cleaning validation, process validation, computerized system validation, or commissioning.
• Ability to write, review, or execute technical documents such as protocols, test scripts, reports, SOPs, batch records, specifications, risk assessments, or deviation investigations.
• Strong problem-solving, communication, and technical writing skills.
• Knowledge of good documentation practices and cGMPs required.
• Knowledge of 21 CFR Part 11, validation lifecycle principles, or risk-based validation approaches preferred.
• Auto CAD experience preferred.
• Flexible to work overtime (paid) as needed.

Pay Range: $33.00 - $43.00 per hour/annualized at $68-89K not including any overtime pay (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.