Technology Transfer Process Engineer

United Pharma Technologies Inc; Spokane (WA); On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

PTO as per state laws

Job summary

United Pharma Technologies Inc in Spokane, WA is seeking a Tech Transfer Process Engineer to support NPI, technology transfer, equipment implementation, commissioning, qualification, and manufacturing readiness in a GMP-regulated sterile environment.

You will lead and support TT/NPI activities, review transfer packages, CQAs, CPPs, and develop URS and qualification strategies while coordinating with MSAT, Manufacturing, Engineering, Quality, and vendors.

Qualifications

• 5+ years in pharma, biotech, or sterile manufacturing.
• Strong hands-on experience in Technology Transfer / NPI and Process Engineering.
• Experience with equipment implementation, commissioning, and qualification.
• Knowledge of CQAs, CPPs, Process Validation, and GMP requirements.
• Experience developing URS, FAT/SAT, and IQ/OQ protocols.
• Strong technical writing and cross-functional coordination skills.

Responsibilities

• Lead and support Technology Transfer and New Product Introduction (NPI) activities.
• Review sponsor transfer packages, process documentation, CQAs, and CPPs.
• Support process development, validation, and manufacturing readiness.
• Develop User Requirement Specifications (URS) and equipment qualification strategies.
• Coordinate equipment design, procurement, installation, startup, and vendor activities.
• Support FAT/SAT, IQ/OQ/PQ, commissioning, and equipment qualification.
• Work with process vessels, mixing systems, isolators, CIP/SIP, autoclaves, and aseptic processing equipment.
• Manage deviations, CAPAs, change controls, and validation documentation.
• Collaborate with MSAT, Manufacturing, Engineering, Quality, Formulation, and equipment vendors.

Skills

5+ years exp

Tech transfer

Equipment install/qual

CQAs/CPPs/GMP

URS/FAT/IQOQ

Technical writing

Job description

Job Title: Tech Transfer Process Engineer

Location: Spokane, WA

Company: United Pharma Technologies Inc

Employment Type: Contract

Job Description:

We are seeking an experienced Technology Transfer / NPI Engineer to support new product introductions, technology transfer, equipment implementation, commissioning, qualification, and manufacturing readiness within a GMP-regulated sterile manufacturing environment.

Key Responsibilities:

• Lead and support Technology Transfer and New Product Introduction (NPI) activities.
• Review sponsor transfer packages, process documentation, CQAs, and CPPs.
• Support process development, validation, and manufacturing readiness.
• Develop User Requirement Specifications (URS) and equipment qualification strategies.
• Coordinate equipment design, procurement, installation, startup, and vendor activities.
• Support FAT/SAT, IQ/OQ/PQ, commissioning, and equipment qualification.
• Work with process vessels, mixing systems, isolators, CIP/SIP, autoclaves, and aseptic processing equipment.
• Manage deviations, CAPAs, change controls, and validation documentation.
• Collaborate with MSAT, Manufacturing, Engineering, Quality, Formulation, and equipment vendors.

Required Skills:

• 5+ years of experience in pharmaceutical, biotech, or sterile manufacturing.
• Strong hands-on experience in Technology Transfer / NPI and Process Engineering.
• Experience with equipment implementation, commissioning, and qualification.
• Knowledge of CQAs, CPPs, Process Validation, and GMP requirements.
• Experience developing and executing URS, FAT/SAT, and IQ/OQ protocols.
• Strong technical writing and cross-functional coordination skills.

Pay Scale: $50 to $55/Hr on W2

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.