Serán BioScience · 3 months ago
Quality Assurance Validation Engineer
Bend, Oregon
Full-time
Onsite
Mid, Senior Level
4+ years expSerán 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 responsible for the review and/or approval of qualification/validation of lifecycle activities associated with facilities, utilities, equipment, process, cleaning, and computerized systems, primarily supporting the new commercial manufacturing facility.
Biotechnology
No H1B
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
Qualification
Required
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
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
Preferred
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
Benefits
Employees are awarded generous PTO accrual
Low-cost health benefits
5% 401(k) contribution that does not require an employee match or vesting
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
Access to pet insurance
Company
Serán BioScience
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dan Smithey, PhD
President, CEO and Founder
Company data provided by crunchbase