Quality Assurance Validation Engineer
Bend, Oregon /
Quality – Quality Assurance /
Full-time Exempt
/ On-site
Serán is seeking a Quality Assurance Validation Engineer to support validation activities of Quality Control and Operations instrumentation within GMP manufacturing. In this role you will be part of a cross functional team that will be involved in the development, execution, and/or approval of qualification and / or validation of facilities, utilities, equipment, process, cleaning, and computerized systems. You will also support validation lifecycle activities and will participate in the generation, review and/or approval of change controls, CAPAs, and deviations.
The development and execution of these deliverables requires direct communication with internal and external cross functional teams. Effective communication is essential for alignment on strategies and approaches, and correcting deficiencies while maintaining good working relationships. A thorough understanding of current regulations and guidelines such as 21 CFR Part 11, EudraLex Volume 4, Annex 15, and GAMP 5 is required.
Duties and Responsibilities
- Generates and/or supports the generation of risk assessments, user requirements specifications (URS), validation plans, change requests, SOPs, CAPAs, and other relevant documents
- Supports validation lifecycle activities to ensure that qualified systems remain in their validated state
- Leads data integrity risk assessments efforts for validated computerized systems
- Leads the validation effort of enterprise and analytical systems at Serán
- Provides assessments and recommendations related to systems integration needed to preserve the integrity of the data lifecycle
- Supports the qualification/validation effort driven by the MSAT group
- Provides support during clients and regulatory audits
- Other related duties as assigned
Required Skills and Abilities
- Comprehension of current regulations and guidelines (e.g., 21 CFR Part 11, 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 a minimum of two of the following: qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation
- Experience performing data integrity risk assessment is preferable
- 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
- Understanding of IT systems, services, and infrastructure is preferred
- Strong time-management skills and the ability to organize and coordinate multiple projects at a time
- 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 science, engineering, or related field with 3-5 years of experience in the pharmaceutical industry
- At least three years of experience performing qualifications and/or validations
Physical Requirements
- Prolonged periods sitting at a desk and working on a computer
- Prolonged periods of mobility between offices and campus buildings
