CQV Engineer

CQV Engineer – Greenfield Biopharmaceutical Project

Location: Holly Springs, North Carolina (Onsite)

Duration: LongTerm Contract

ryWe are seeking experienced Commissioning, Qualification, and Validation (CQV) Engineers to support a large-scale greenfield biopharmaceutical manufacturing facility project in Holly Springs, NC. This role will be responsible for executing commissioning, startup, qualification, and validation activities for GMP manufacturing systems, process equipment, and critical utility system

s.The ideal candidate will possess hands-on experience supporting facility startup and operational readiness activities within pharmaceutical, biotechnology, or life sciences environments. Candidates should be capable of independently executing CQV activities while collaborating with engineering, automation, manufacturing, and quality teams to ensure project milestones are achieve

d.
Key Responsibilit

• iesExecute commissioning, qualification, startup, and validation activities for GMP manufacturing equipment and utility syste
• ms.Develop, review, and execute Commissioning Test Plans (CTPs), Installation Qualification (IQ), Operational Qualification (OQ), and system turnover documentati
• on.Support startup, troubleshooting, and operational readiness of process equipment and clean utility syste
• ms.Review engineering documentation including P&IDs, design specifications, vendor documentation, and system impact assessmen
• ts.Coordinate closely with Engineering, Automation, Validation, Quality Assurance, and Operations teams throughout project executi
• on.Participate in system walkdowns, Mechanical Completion (MC) verification, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SA
• T).Support punch list management, deviation investigations, change controls, and corrective actio
• ns.Ensure all CQV activities are executed in compliance with GMP, GDP, and applicable regulatory requiremen
• ts.Prepare and maintain qualification documentation in accordance with project and quality standar
• ds.Drive project schedules and support aggressive startup timelines within a fast-paced greenfield environme

nt.
Required Qualificat

• ionsBachelor's degree in Engineering or a related technical discipl
• ine.Minimum 5 years of Commissioning, Qualification, Validation (CQV), or Startup experience within pharmaceutical, biotechnology, or life sciences industr
• ies.Proven experience supporting greenfield manufacturing facility proje
• cts.Strong experience commissioning and qualifying critical utility systems, includ
• ing:Water for Injection (
• WFI)Clean Steam Sys
• temsHVAC Sys
• temsCompressed Air Sys
• temsPurified Water Sys
• temsCIP/SIP Sys
• temsExperience supporting upstream and downstream bioprocess manufacturing equipm
• ent.Strong knowledge of GMP regulations, GDP practices, and validation lifecycle methodolog
• ies.Demonstrated experience authoring and executing qualification protocols and commissioning documentat
• ion.Ability to work independently and manage multiple priorities in a startup environm
• ent.Excellent communication, collaboration, and problem-solving ski

lls.
Preferred Qualifica

• tionsExperience working with DeltaV, Rockwell Automation, or similar process control sys
• tems.Previous experience supporting biologics, sterile manufacturing, or aseptic processing facili
• ties.Familiarity with electronic validation systems such as Kneat, ValGenesis, or equivalent platf
• orms.Experience supporting large-scale facility startup, operational readiness, and technology transfer initiat

ives.
Key

• SkillsCommissioning & S
• tartupEquipment Qualification (IQ/
• OQ/PQ)GMP Comp
• lianceCritical Uti
• litiesUpstream & Downstream Proc
• essingFAT/SAT Exe
• cutionMechanical Comp
• letionDeviation Mana
• gementChange C
• ontrolValidation Documen
• tationP&ID
• ReviewSystem Tu
• rnoverCQV Lifecycle Mana
• gementBiopharmaceutical Manufac