Qualification Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

United Pharma Technologies Inc ยท 1 day ago

Qualification Engineer

positionMichigan, United States
timeContract
remoteOnsite
seniorityMid Level

United 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
check
H1B Sponsor Likelynote
Hiring Manager
Shakkara Likitha
linkedin

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

CQV activitiesFDA complianceGMP standardsISO 13485Validation documentationRisk assessmentsContinuous improvementCross-functional collaboration

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

twittertwitter
company-logo
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.
dateFounded in 2010
location
South Plainfield, New Jersey, USA
people-size201-500 employees
web-link
https://unitedpharma.us/

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 Stage
Total Funding
unknown
2022-07-18Acquired

Leadership Team

leader-logo
Babjee M
Founder/ Srategic Partner
linkedin
Company data provided by crunchbase