United Pharma Technologies Inc ยท 8 hours ago
Senior Validation Engineer
North Carolina, United States
Contract
Onsite
Senior Level
5+ years expUnited Pharma Technologies Inc is seeking an experienced CQV Engineer to support Commissioning, Qualification, and Validation activities for a pharmaceutical/biotechnology manufacturing facility. This role is responsible for ensuring compliance with GMP, FDA, and regulatory requirements while managing and executing CQV protocols and collaborating with cross-functional teams.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Hemasundar Annam
Responsibilities
Independently author and execute CQV protocols, including commissioning, IQ, OQ, PQ, and final validation reports with minimal supervision
Plan, manage, and prioritize CQV activities to meet interim milestones and overall project schedules
Provide input into validation scope, testing strategy, and timing to support project planning and execution
Represent the Validation function on cross-functional project teams, ensuring CQV deliverables align with project timelines
Collaborate closely with Engineering, Automation, Quality, Manufacturing, and other stakeholders to complete validation lifecycle activities
Communicate effectively (written and verbal) regarding task status, risks, deviations, discrepancies, and schedule impacts
Perform independent troubleshooting to identify testing or setup issues and recommend appropriate corrective actions
Develop validation strategies in alignment with site SOPs, regulatory expectations, and industry best practices
Review and interpret technical documentation such as URS, FS, P&IDs, and design specifications, translating requirements into executable test cases
Support multiple concurrent projects in a fast-paced, regulated environment
Ensure strict compliance with Good Documentation Practices (GDP/GDocP)
Provide flexibility to support occasional off-hours or weekend onsite validation activities as project needs require
Qualification
Required
Minimum 5 years of CQV and/or cleaning validation experience within a GMP-regulated pharmaceutical or biotechnology environment
Candidates with slightly less experience may be considered with targeted hands-on training prior to assignment
Hands-on experience with commissioning and qualification of manufacturing process equipment
Experience working with PLC-controlled automated systems
Proven experience developing and executing temperature mapping studies (empty and loaded chambers), including worst-case load justification
Experience performing requalification and periodic reviews to ensure continued validated state
Experience supporting cleaning validation and/or cleaning verification, including: Cleaning cycle development, Rinse sampling, Surface swabbing, Visual inspections
Ensure strict compliance with Good Documentation Practices (GDP/GDocP)
Provide flexibility to support occasional off-hours or weekend onsite validation activities as project needs require
Preferred
Familiarity with Rockwell PlantPAx is preferred but not required
Prior testing experience on systems utilizing Unicorn software is preferred
Strong understanding of GMP, FDA, and global regulatory requirements
Excellent analytical, problem-solving, and documentation skills
Ability to work independently with minimal supervision
Strong collaboration and communication skills in cross-functional teams
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