MSAT Engineer

United Pharma Technologies Inc; Spokane (WA); On-site; USD 76,000 - 83,000; Full time

Benefits offered by this job

Health Insurance

401(k) Plan

PTO

Job summary

United Pharma Technologies Inc. is seeking a Technology Transfer / NPI Engineer to support the transfer of pharmaceutical products into commercial sterile manufacturing operations.

The role translates sponsor transfer packages into manufacturing processes, equipment requirements, qualification plans, and operational readiness activities. This position involves owning projects from initial transfer through equipment qualification and manufacturing handoff, collaborating with sponsors,

Qualifications

• 5+ years in pharmaceutical/biotech manufacturing.
• Experience supporting technology transfer and NPI projects.
• Knowledge of CQAs, CPPs, and process validation.
• Experience developing IQ/OQ protocols.
• Experience with deviations, CAPAs, and change controls.

Responsibilities

• Support new product introductions (NPI) and technology transfers.
• Interpret sponsor transfer packages and process documentation.
• Develop and implement IQ/OQ protocols.
• Coordinate equipment procurement, installation, and startup.
• Maintain GMP-compliant qualification documentation and TRACKWise records.
• Lead or support FAT and SAT planning and execution.
• Ensure manufacturing readiness and operational handoff.
• Collaborate with MSAT, QA, Manufacturing, and vendors.

Skills

Technology Transfer

New Product Introduction

CQV Knowledge

MSAT

Cross-functional Collaboration

Tools

TrackWise

Job description

We are seeking a Technology Transfer / NPI Engineer to support the transfer of pharmaceutical products into commercial sterile manufacturing operations. This individual will serve as a key technical resource responsible for translating sponsor transfer packages into manufacturing processes, equipment requirements, qualification plans, and operational readiness activities.

This is not a traditional CQV execution role. The ideal candidate will have a combination of Technology Transfer, MSAT, Process Engineering, Equipment Implementation, and CQV experience and be comfortable owning projects from initial transfer through equipment qualification and manufacturing handoff.

The successful candidate will work closely with sponsors, Manufacturing, Engineering, Quality, Formulation, and equipment vendors to ensure successful implementation of new products and processes.

Primary 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.
• Equipment Procurement & Implementation
• 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.
• Quality Systems & Compliance
• 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 Experience

• 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 Experience

• Sterile manufacturing environments.
• Fill-finish operations.
• Isolators.
• Aseptic processing equipment.
• Process vessels and tanks.
• Mixing systems.
• CIP/SIP systems.
• Autoclaves.
• Cold storage and temperature mapping.
• FAT/SAT execution.
• Process validation and PPQ.
• TrackWise.
• Manufacturing Science & Technology (MSAT).

Pay Rate: $55 to $60/Hr on W2

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.