United Pharma · 8 hours ago
Validation Engineer -Senior CQV
North Carolina, United States
Contract
Onsite
Senior Level, Lead/Staff
9+ years expUnited Pharma is a prominent pharmaceutical manufacturing company seeking a CQV Engineer to support a high-visibility capital expansion project at an operational GMP facility. This fully onsite role requires a hands-on professional with experience in commissioning, qualification, and validation of facility and process equipment, collaborating closely with various teams throughout construction and qualification phases.
Staffing & Recruiting
Hiring Manager
Chandra Sekhar.s
Responsibilities
Author, review, and maintain project lifecycle documentation, including:
User Requirement Specifications (URS)
Functional and Design Specifications (FS/DS)
Standard Operating Procedures (SOPs)
Risk Assessments, FMEA, and HAZOP documentation
Gap Assessments
Management of Change (MOC) documentation
Project closeout and turnover packages
Project change requests
Conduct daily construction job walks and provide onsite CQV support
Develop, manage, and execute construction-related documentation, including:
Safety Management Plans
Job Hazard Analyses (JHA)
Lockout/Tagout (LOTO) plans
Hot Work and Permit-to-Work documentation
Disruptive construction activity requests
Detour plans, construction signage, and plant-wide communications
Assist with coordination and oversight of construction personnel
Develop and maintain Construction Control Plans
Author, execute, review, and approve commissioning protocols
Perform system function testing and operational verification
Support:
Bill of Materials (BOM) updates
Preventive Maintenance (PM) generation
Asset lifecycle documentation
Engineering drawing updates
Support Site Acceptance Testing (SAT) and system readiness reviews
Prepare commissioning summary reports
Author, execute, and approve Installation, Operational, and Performance Qualification protocols
Verify equipment installation against manufacturer specifications and engineering drawings
Execute operational testing under defined process conditions
Document all test results, deviations, and corrective actions
Support deviation investigations and resolution activities
Generate qualification summary and final validation reports
Support process validation efforts to ensure consistent product quality
Execute cleaning validation activities to prevent cross-contamination
Perform qualification of critical facility systems
Support validation of software systems used for data management and process control
Identify, evaluate, and document risks impacting product quality and patient safety
Develop risk mitigation strategies and contingency plans
Manage change control activities related to equipment, utilities, and process updates
Support internal and external quality audits
Train operations and technical personnel on validated systems and procedures
Provide startup and ramp-up support for facility systems and process equipment
Compile comprehensive validation reports with conclusions and recommendations for continued monitoring
Qualification
Required
Bachelor's degree in Engineering or a related scientific discipline
9 years of CQV or Validation Engineering experience within the pharmaceutical or regulated life sciences industry
Demonstrated experience with Facilities CQV, including EMPO, IOV, and IOPQ activities
Hands-on experience with mixing systems, vessels, and temperature mapping
Strong background executing IQ/OQ for process equipment, including: Centrifuges, Filter presses, Processing tanks and vessels
Excellent technical writing and documentation capabilities
Strong verbal communication skills and ability to work cross-functionally
Experience supporting capital projects and performing onsite construction job walks
Ability to multitask effectively while maintaining a positive, solutions-oriented attitude
Preferred
Facility and utility systems such as WFI, clean steam, compressed air, nitrogen, and alcohol systems
CIP systems and skids
Cleaning validation activities
Additional hands-on experience with centrifuges and filter press systems
Company
United Pharma
United Pharma Solutions is a professional company dedicated to business development in the pharmaceutical industry.
11-50 employees
H1B Sponsorship
United Pharma 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
Early StageCompany data provided by crunchbase