Senior Validation Engineer

Seranbio; Bend (OR); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

4 weeks PTO

401(k) retirement plan

Health insurance

Life and disability insurance

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience is seeking an experienced Senior Validation Engineer to lead CQ/qualification efforts for OSD manufacturing facilities, utilities, and process equipment. You will coordinate cross-functional teams, develop validation plans, and ensure regulatory compliance with FDA/EU standards, advancing tech transfer from clinical to commercial scale.

Applicants should have 8+ years in pharma validation, strong leadership, and proven ability to manage multiple projects in a fast-paced

Qualifications

• Knowledge of cGMPs guidelines and regulations.
• Experience with CQV planning and validation in pharma.
• Familiar with FDA/MHRA/EU regulatory expectations.
• 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.
• Ability to manage multiple projects and collaborate in cross-functional teams.
• Strong time-management skills and the ability to coordinate multiple projects.
• Communicates effectively and maintains productive relationships with coworkers and clients.
• Ability to prioritize tasks and keep leadership apprised of timelines.
• Demonstrates leadership and ability to coach cross-functional teams.
• Experience in FAT/SAT of process equipment and knowledge of OSD equipment.
• Proficiency in Microsoft Office and ability to learn new software.
• Bachelor's degree in relevant technical field.
• Requires a minimum of 8 years of quality, validation, or engineering experience in non-sterile pharma.
• Understanding of process equipment, utilities, cleaning, and QA systems in pharma/biotech.
• GMP compliance experience, including 21 CFR Part 11 and GAMP 5.

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

Skills

Leadership

Project management

Communication

Problem solving

Interpersonal skills

Time management

Cross-functional collaboration

Education

Bachelor's degree in relevant technical field

Tools

Microsoft Office

Job description

Serán 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 be part of a cross functional team that will plan and execute commissioning/qualification (CQ) projects for equipment and critical utilities process, tech transfer of manufacturing process from clinical to commercial site, and subsequent validation for process, cleaning, and computerized systems to support commercial distribution of non-sterile pharmaceutical products. Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams. Those with less experience are encouraged to apply.

As a critical member of the Commercial Steering Committee, the Senior Validation Engineer will be responsible for planning and execution of CQ and validation projects. In order to perform this task, applicants require a thorough understanding of the manufacturing processes and systems as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Successful candidates will understand that the development and execution of CQ and validation projects requires communication with internal and external cross functional teams. Demonstrated ability with effective communication is essential for identifying required information, alignment of strategies, and mitigation risks while maintaining good working relationships.

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

Qualifications

• Demonstrates knowledge of cGMPs guidelines and regulations acquired through education, experience, and training
• Preference for those who posses knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA)
• Showcases foundational understanding of the compliance and technical requirements for the application of various scientific concepts used in developing different dosage forms of pharmaceutical products (primarily oral solid dose, while experience with sterile products is desired)
• 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
• 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
• Experience in FAT/SAT of process equipment, and knowledge operating principles of typical OSD process equipment preferred.
• Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
• 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
• Prolonged periods of sitting or standing at a desk and working on a computer
• Prolonged periods of sitting or standing in a manufacturing environment
• Must be able to lift fifteen pounds at times
• Adheres to consistent and predictable in-person attendance

Benefits

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.

Location

The Corporate Headquarters of Serán BioScience are located 63047 Layton Ave, Bend, OR 97701

Additional Information

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon. 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.