Quality Assurance, Validation Engineer

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 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

• Serán 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.
• Serán 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 Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701