Validation Engineer

United Pharma Technologies Inc; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma Technologies Inc. is seeking a process validation professional to support commissioning and qualification of upstream and downstream bioprocess equipment in a large-scale biologics facility.

You will verify P&ID field data, perform system walkdowns, and contribute to turnover packages and calibration documentation. The role requires hands-on experience with DeltaV OQ, GMP commissioning, and startup activities, along with a strong background in pharma/biotech manufacturing and

Qualifications

• Strong pharmaceutical/biotech manufacturing background.
• Experience with upstream and downstream process equipment.
• Biologics and stainless-steel manufacturing environments preferred.
• Hands-on P&ID field verification, system walkdowns, turnover packages, punch lists, and calibration documentation.

Responsibilities

• Perform field verification of P&IDs, equipment data sheets, vendor drawings, isometrics, utility connections, and system boundaries.
• Conduct system-completion walkdowns and turnover-package reviews.
• Review punch-list closure, calibration records, weld documentation, and engineering redlines.
• Execute commissioning, IQ/OQ, and operational qualification activities.
• Support DeltaV operational qualification and troubleshooting.
• Identify and resolve equipment startup, automation logic, valve sequencing, and cleaning-cycle issues.

Skills

P&ID verification

Field walkdowns

IQ/OQ

DeltaV OQ

GMP commissioning

Startup activities

Tools

Kneat

Smartsheet

Microsoft Office

Job description

The project involves commissioning and qualification of upstream and downstream process equipment, automation systems, and associated utilities within a large-scale biologics manufacturing facility.

Key Responsibilities:

• Perform field verification of P&IDs, equipment data sheets, vendor drawings, isometrics, utility connections, and system boundaries.
• Conduct system-completion walkdowns and turnover-package reviews.
• Review punch-list closure, calibration records, weld documentation, and engineering redlines.
• Execute commissioning, IQ/OQ, and operational qualification activities.
• Support DeltaV operational qualification and troubleshooting.
• Identify and resolve equipment startup, automation logic, valve sequencing, and cleaning-cycle issues.

Upstream Equipment:

• Bioreactors
• Media preparation systems
• Incubators
• Pumps

Downstream Equipment:

• Chromatography skids
• UF/DF systems
• Viral filtration skids
• Depth filtration systems
• Buffer preparation vessels
• Product hold tanks

Technical Environment:

• Kneat
• Smartsheet
• Microsoft Office

Ideal Background:

• Strong pharmaceutical, biotechnology, or life sciences manufacturing background.
• Experience with upstream and/or downstream process equipment.
• Experience in large-molecule / biologics and stainless-steel manufacturing environments.
• Hands-on experience with P&ID field verification, system walkdowns, turnover packages, punch lists, and calibration documentation.
• Experience executing DeltaV OQ activities.
• Strong knowledge of GMP commissioning, qualification, and startup activities.