Quality Assurance Validation Engineer - Serán BioScience
Bend, OR 97701
About the Job
Serán is seeking a Quality Assurance Validation Engineer to support validation activities of 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
- Supports the qualification/validation effort driven by the MSAT group, including qualification of OSD systems, process validation, and cleaning validation
- 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 cleaning or process validation
- Experience performing cleaning and/or process validation is preferred
- 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
- Experience performing equipment qualification for OSD systems is required
- 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
- Minimum of 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
Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
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. Serán fully funds employees and their household with dental, vision and one medical plan option. 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 pet programs as well.
PI255219110
Source : Serán BioScience