United Pharma Technologies Inc · 1 day ago
Validation Engineer
California, United States
Contract
Onsite
Mid, Senior Level
3+ years expUnited Pharma Technologies Inc is seeking an experienced Validation Engineer to support pharmaceutical manufacturing operations. This role will be responsible for executing validation activities for equipment, utilities, facilities, and computerized systems in compliance with cGMP, FDA, and global regulatory requirements.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Hemasundar Annam
Responsibilities
Lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing equipment, utilities, and facilities
Develop, review, and execute validation documents including:
Validation Master Plans (VMP)
Commissioning protocols
IQ, OQ, PQ protocols and reports
Support equipment qualification for process equipment, packaging equipment, and laboratory instruments
Perform validation activities for utilities and systems such as HVAC, cleanrooms, water systems (PW/WFI), compressed air, and steam
Ensure validation activities comply with cGMP, FDA, EU GMP, and ICH guidelines
Support deviation investigations, CAPAs, and change control related to validated systems
Participate in risk assessments (FMEA, impact assessments) for validation and qualification activities
Collaborate with Engineering, Quality Assurance, Manufacturing, and Automation teams
Support regulatory inspections and audits by providing validation documentation and responses
Assist with lifecycle management, periodic reviews, and requalification activities
Qualification
Required
Bachelor's degree in Engineering, Science, or a related technical field
3–8+ years of validation experience in the pharmaceutical or biopharmaceutical industry
Strong hands-on experience with CQV execution
In-depth knowledge of IQ/OQ/PQ, GMP regulations, and validation lifecycle
Experience with equipment, utilities, and/or facility qualification
Familiarity with FDA 21 CFR Parts 210, 211, and applicable global regulations
Ability to work independently in a fast-paced, regulated environment
Strong technical writing and documentation skills
Preferred
Experience with aseptic processing, sterile manufacturing, or biologics
Exposure to greenfield or brownfield projects
Knowledge of GAMP 5 and computerized system validation (CSV)
Experience supporting FDA or regulatory inspections
Validation experience with automation systems (DeltaV, Siemens, Rockwell) is a plus
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