Senior Validation Engineer, OSD CQV & Tech Transfer

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 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