United Pharma Technologies Inc ยท 2 days ago
Qualification Engineer
Michigan, United States
Contract
Onsite
Mid LevelUnited Pharma Technologies Inc is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for regulated manufacturing environments. The ideal candidate will have hands-on experience in medical device or pharmaceutical facilities, ensuring systems and equipment meet FDA, GMP, and ISO regulatory standards.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Shakkara Likitha
Responsibilities
Lead and execute Commissioning, Qualification, and Validation (CQV) activities for equipment, utilities, and facilities
Develop and execute validation documentation including:
URS, FRS, IQ, OQ, PQ
Validation protocols and final reports
Perform equipment qualification for manufacturing and packaging systems
Support cleanroom validation, HVAC qualification, and environmental monitoring
Conduct risk assessments (FMEA, risk-based validation approaches)
Ensure compliance with FDA, cGMP, ISO 13485, and GAMP 5 guidelines
Review vendor documentation and FAT/SAT reports
Collaborate with cross-functional teams (Quality, Manufacturing, Engineering, Regulatory)
Support process validation and revalidation activities
Participate in audits and inspections (FDA, internal, customer audits)
Identify and implement continuous improvement initiatives
Qualification
Required
Hands-on experience in medical device or pharmaceutical facilities
Experience in commissioning, qualification, and validation activities for regulated manufacturing environments
Ability to lead and execute Commissioning, Qualification, and Validation (CQV) activities for equipment, utilities, and facilities
Experience in developing and executing validation documentation including URS, FRS, IQ, OQ, PQ
Experience in performing equipment qualification for manufacturing and packaging systems
Experience in supporting cleanroom validation, HVAC qualification, and environmental monitoring
Experience in conducting risk assessments (FMEA, risk-based validation approaches)
Knowledge of compliance with FDA, cGMP, ISO 13485, and GAMP 5 guidelines
Experience in reviewing vendor documentation and FAT/SAT reports
Ability to collaborate with cross-functional teams (Quality, Manufacturing, Engineering, Regulatory)
Experience in supporting process validation and revalidation activities
Experience in participating in audits and inspections (FDA, internal, customer audits)
Ability to identify and implement continuous improvement initiatives
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.
Founded in 2010
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