United Pharma Technologies Inc · 8 hours ago
Process Validation Engineer
Sturtevant, WI
Contract
Onsite
Senior Level
5+ years expUnited Pharma Technologies Inc is a company focused on the installation and validation of silicone injection molding machines. They are seeking a Process Validation Engineer to support equipment installation, commissioning, and qualification within a regulated manufacturing environment, while ensuring compliance with quality standards.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Hemasundar Annam
Responsibilities
Support equipment installation, commissioning, and qualification (IQ/OQ/PQ) for silicone injection molding machinery
Assist with new tooling installation and tooling replacement/changeovers
Author, execute, and review validation documentation, including:
URS
Risk Assessments (FMEA or equivalent)
IQ / OQ / PQ protocols and reports
Traceability matrices
Lead hands-on protocol execution, testing, and data analysis
Support process validation activities following equipment qualification
Collaborate with Engineering, Manufacturing, Quality, and external vendors
Ensure compliance with GMP, ISO 13485, and internal quality system requirements
Maintain inspection-ready documentation and support audit readiness
Qualification
Required
5+ years of experience as a Process or Equipment Validation Engineer
Hands-on experience executing IQ/OQ/PQ for manufacturing equipment
Strong understanding of equipment qualification and validation lifecycle
Experience working in ISO 13485 and/or GMP-regulated environments
Proven ability to independently manage validation activities in a fast-paced setting
Preferred
Experience with injection molding equipment (silicone injection molding strongly preferred)
Experience supporting tooling installation or tooling changeovers
PPAP (Production Part Approval Process) experience
Background in medical device or pharmaceutical manufacturing
Experience working in a small or mid-sized manufacturing organization
Company
United Pharma Technologies Inc
United Pharma Technologies (UPT) is a global life-science services company delivering CQV, validation, quality, automation, and regulatory compliance solutions to the pharmaceutical, biotechnology, medical device, and diagnostics sectors.
201-500 employees
H1B Sponsorship
United Pharma Technologies Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Growth StageTotal Funding
unknown2022-07-18Acquired
Leadership Team
Babjee M
Founder/ Srategic Partner
Company data provided by crunchbase