What are the responsibilities and job description for the New Product Introduction Engineer position at United Pharma Technologies Inc?
Job Title: New Product Introduction Engineer (NPI Engineer)
Company: United Pharma Technologies
Duration: Long Term
Location: Spokane, WA
Employment Type: Contract
Job Responsibilities
- Support new product introductions (NPI) and technology transfer activities.
- Review and interpret sponsor transfer packages and process documentation.
- Understand and apply Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
- Support process development, process validation, and manufacturing readiness activities.
- Partner with formulation, MSAT, manufacturing, and quality teams to implement transferred processes.
- Serve as a technical resource during process transfer and startup activities.
- Develop and/or own User Requirement Specifications (URS).
- Participate in equipment specification development and design reviews.
- Work with equipment vendors throughout design, procurement, fabrication, installation, and startup.
- Support project management activities associated with equipment delivery and installation.
- Coordinate cross-functional activities required to bring systems into GMP operation.
- Lead or support FAT and SAT planning, coordination, and execution.
- Author, review, and execute IQ/OQ protocols.
- Coordinate performance qualification (PQ) requirements with manufacturing and quality teams.
- Develop qualification strategies and validation documentation.
- Support operational readiness and manufacturing handoff activities.
- Ensure compliance with GMP requirements and site quality systems.
- Manage or support deviations, CAPAs, and change controls.
- Work within TrackWise or similar quality management systems.
- Support investigations and resolution of qualification and startup issues.
- Maintain audit-ready documentation throughout the project lifecycle.
Required Qualifications
- 5 years of experience in pharmaceutical, biologics, biotech, or sterile manufacturing environments.
- Direct experience supporting technology transfer and/or new product introduction projects.
- Working knowledge of CQAs, CPPs, process development, and process validation.
- Experience developing and executing IQ/OQ protocols.
- Experience supporting equipment qualification and commissioning activities.
- Experience working with deviations, CAPAs, and change controls.
- Strong technical writing skills and ability to develop qualification documentation.
- Ability to work effectively across Engineering, Manufacturing, Quality, MSAT, and vendor teams.
Preferred Qualifications
- Experience in sterile manufacturing environments.
- Experience with fill-finish operations.
- Experience with isolators.
- Experience with aseptic processing equipment.
- Experience with media fills.
- Experience with process vessels and tanks.
- Experience with mixing systems.
- Experience with CIP/SIP systems.
- Experience with autoclaves.
- Experience with cold storage and temperature mapping.
- Experience with FAT/SAT execution.
- Experience with process validation and PPQ.
- Experience with TrackWise.
- Experience in Manufacturing Science & Technology (MSAT).
Pay Scale
Anticipated hourly pay range: $55 - $60/Hr
Benefits
Employees hired into this position are eligible for the following 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 paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.
Salary : $55 - $60