Job Title: Senior CQV / Technology Transfer Engineer
Location: Spokane, WA - 100% Onsite
Duration: 6-month contract with strong extension potential
Experience: 5+ years
Pay: $60/hr on W2
Position Overview
Seeking experienced CQV / Technology Transfer Engineers to support pharmaceutical manufacturing expansion, new equipment installations, and product transfer initiatives. This hands-on role requires independent execution and ownership across technology transfer, equipment specifications, design reviews, procurement support, commissioning, qualification, and manufacturing readiness. Responsibilities will align with each consultant's technical strengths and project needs.
Key Responsibilities
- Technology Transfer and Process Readiness
- Support technology transfer and new product introduction (NPI) projects from planning through manufacturing implementation.
- Interpret Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) and translate them into equipment requirements, qualification testing, and manufacturing controls.
- Assess formulation and filling capabilities against product and process requirements.
- Support process development, process validation, manufacturing startup, and operational readiness.
- Coordinate sponsor-driven transfer activities with Engineering, Manufacturing, Quality, Formulation, and Project teams.
- Equipment Delivery and Project Ownership
- Own the development and maintenance of User Requirement Specifications (URSs) and equipment specifications.
- Support equipment procurement, vendor evaluations, and technical discussions.
- Lead equipment design reviews to confirm alignment with process, GMP, operational, and qualification requirements.
- Manage assigned equipment delivery and installation activities, including schedules, vendor coordination, dependencies, and issue resolution.
- Coordinate or execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Commissioning, Qualification, and Validation
- Plan and execute commissioning and qualification activities for manufacturing equipment and supporting systems.
- Independently author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols and prepare associated reports.
- Define and communicate Performance Qualification (PQ) requirements and coordinate execution with relevant teams.
- Develop qualification strategies and support equipment startup, troubleshooting, and readiness assessments.
- Investigate and resolve qualification discrepancies in accordance with GMP requirements and site procedures.
- Support temperature mapping, storage qualification, and media fill activities as applicable.
- Documentation and Compliance
- Develop and revise SOPs, URSs, qualification protocols, technical reports, and supporting validation documentation.
- Maintain accurate, complete, and traceable project and qualification records.
- Coordinate technical reviews and approvals across functional teams.
- Support regulatory inspection and audit readiness.
Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- Minimum 5 years of relevant experience in pharmaceutical, biotechnology, biologics, or sterile manufacturing.
- Hands-on experience in CQV, equipment qualification, technology transfer, manufacturing engineering, technical operations, or facility expansion projects.
- Demonstrated ownership of assigned equipment or project activities from requirements definition through installation and qualification.
- Strong understanding of commissioning principles and the IQ/OQ/PQ lifecycle.
- Ability to independently author qualification protocols, reports, specifications, and technical documentation.
- Working knowledge of CQAs, CPPs, process development, and process validation.
- Experience assessing formulation and/or filling equipment capabilities against manufacturing needs.
- Experience coordinating or executing FAT/SAT and IQ/OQ activities.
- Strong GMP knowledge, technical writing, organization, communication, and cross-functional coordination skills.
- Ability to work independently with minimal oversight and support projects onsite in Spokane, WA.
Preferred Experience:
- Sterile manufacturing, aseptic filling, and media fill support.
- Process vessels, manufacturing tanks, mixing and formulation equipment.
- CIP systems, sterility support equipment, manufacturing fixtures, and general GMP equipment.
- Ultra-low temperature freezers, walk-in freezers, cold rooms, refrigerated storage, and temperature-controlled warehouses.
- Temperature mapping and environmental/storage qualification.
- Sponsor-led technology transfers, NPI, manufacturing startup, and facility expansion.
- Equipment procurement, vendor management, and project delivery.
Recruiter Contact
Pavani Samboju
Email: pavani.samboju@intellectt.com
Phone: 732-204-6899
Benefits:
Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.
Equal Employment Opportunity
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law