Quality Assurance Validation Engineer

Quality Assurance Validation Engineer

Sern BioScience is expanding and looking for a Quality Assurance Validation Engineer with industry experience to join at this exciting time. The QA Validation Engineer will be part of a cross functional team that will be responsible for the review and / or approval of qualification / validation of all the lifecycle activities associated with facilities, utilities, equipment, process, cleaning, and computerized systems. The primary focus of this position will be to support the new commercial manufacturing facility.

The development and execution of these deliverables requires direct communication with internal and external cross functional teams. Successful candidates will understand that effective communication is essential for alignment on strategies and approaches, and correcting deficiencies while maintaining good working relationships. Qualified candidates will have a thorough understanding of current regulations and guidelines such as but not limited to 21 CFR Parts 11, 210, and 211, EudraLex Volume 4, Annex 15, and GAMP 5 is required.

Sern BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a principled and positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application!

Duties and Responsibilities

Generates and / or supports the generation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documents

Supports validation lifecycle activities such as, but not limited to, change management, periodic reviews, and re-qualification to ensure that qualified systems remain in their validated state

Makes compliance decisions to support clinical and commercial operations

Mentors colleagues on the reasons or justifications of the requirements and practices

Drives process improvement initiatives

Provides support during clients and regulatory audits

Performs other related duties as assigned

Responsibilities may increase in scope to align with company initiatives

Required Skills and Abilities

Understanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort

Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort

Hands-on experience with the qualification of facilities, utilities, equipment and / or computerized systems, cleaning or process validation (Experience in at least two of these areas is required)

Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team

Strong time-management skills and the ability to organize and coordinate multiple projects at a time

Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company

Ability to prioritize tasks and to keep leadership apprised of performance to timelines

Accepts feedback from a variety of sources and constructively manages conflict

Experience in Oral Solid Dose operations and spray drying is preferable

Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems

Education and Experience

Bachelor's degree in a science, engineering, or related field

Minimum of 4 years required within pharmaceutical industry, with preference given to those with 5-10 years of experience

Minimum of 4 years of experience performing qualifications and / or validations is required

Physical Requirements

Prolonged periods sitting at a desk and working on a computer

Prolonged periods of mobility between offices and campus buildings

Adheres to consistent and predictable in-person attendance

Level and compensation will be based on experience. Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary :

Sern employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Sern covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.

The Corporate Headquarters of Sern BioScience are located at 63047 Layton Ave, Bend, OR 97701