Serán BioScience · 22 hours ago
Senior Validation Engineer
Bend, Oregon
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expSerán BioScience is motivated to find an industry-experienced Validation Engineer to support the development of a new commercial manufacturing facility. The Senior Validation Engineer will lead commissioning and qualification projects for equipment and processes in the pharmaceutical manufacturing sector, ensuring compliance with relevant regulations and guidelines.
Biotechnology
No H1B
Responsibilities
Leads the commissioning and qualification (C&Q) of new and existing equipment and systems for OSD manufacturing, facilities, and utilities, ensuring compliance with cGMP, FDA, and EU regulatory standards
Supports the clinical technology transfer and operations in design, scale-up, optimization, and troubleshooting of OSD processes and equipment
Develops and executes protocols for equipment IQ/OQ/PQ in alignment with site validation master plans and project timelines
Collaborates with cross-functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgets
Manages installation activities, equipment FAT/SAT execution, and vendor coordination to ensure technical and compliance requirements are met
Collaborates with multidisciplinary team to complete change controls, deviations investigations, and CAPAs as required
Supports regulatory inspections and client audits
Performs other related duties as assigned
Responsibilities may increase in scope to align with company initiatives
Qualification
Required
Demonstrates knowledge of cGMPs guidelines and regulations acquired through education, experience, and training
Bachelor's degree in relevant technical field
Requires a minimum of 8 years of quality, validation, or engineering experience in non-sterile clinical and commercial pharmaceutical manufacturing
Fundamental understanding of process equipment, utilities, manufacturing process, cleaning process and Quality systems used in the pharmaceutical/biotech industry
8 years of GMP compliance experience, including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others
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 once
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 timelines
Accepts feedback from a variety of sources and constructively manages conflict
Demonstrates leadership skills with ability to motivate and coach cross functional teams
Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
Preferred
Experience with regulatory expectations and industry practices for CQ and Validation using Product Lifecycle approach
Experience with designing CQV plans for Facilities, Utilities, and Process equipment desired
Experience in FAT/SAT of process equipment, and knowledge operating principles of typical OSD process equipment preferred
Benefits
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