6244 - CIP (Clean-in-Place) Engineer

We are seeking a Clean-in-Place (CIP) Engineer with hands-on experience overseeing the commissioning and qualification of Clean-In-Place (CIP) systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.

Responsibilities

Serve as the commissioning and qualification (C&Q) lead for CIP systems; Develop and optimize CIP cleaning cycles to meet operational and quality standards; Supervise the safe introduction and handling of caustic solutions during cleaning cycle development; Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications; Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES); Engage with design engineers and SMEs to clarify system intent and operational requirements; Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation; Create Commissioning Test Plans that translate design intent into testable steps; Coordinate with the Automation Team to incorporate all automation functional testing; Collaborate with SMEs to ensure system requirements are accurately reflected in test plans; Develop Installation, Operational, and Qualification (IOQ) protocols; Prepare and submit summary reports documenting commissioning and qualification activities; Take custody of the system post-construction and maintain ownership through C&Q completion; Perform Lockout/Tagout (LOTO) for system safety; Conduct pre-startup safety checks and risk assessments; Prepare daily pre-task plans and verify team readiness for safe execution; Attend daily commissioning meetings to coordinate activities; Execute commissioning and IOQ protocols; Resolve issues arising during execution; Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required

Requirements

Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline; 10+ years of role-specific experience; Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments; Hands-on experience with CIP systems and automated cleaning processes; Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports); Ability to work independently while coordinating with cross-functional project teams; Strong technical documentation and communication skills; Experience using digital validation platforms such as Kneat; Experience supporting FAT/SAT, commissioning, and equipment startup; Familiarity with automated process systems and PLC-based equipment; Experience in biologics or large-scale biopharmaceutical manufacturing environments; Onsite job requirement in Apex, NC

Benefits

High growth potential and fast-paced organization with a people-focused culture; Competitive pay plus performance-based incentive programs; Company-paid Life, Short-Term, and Long-Term Disability Insurance; Medical, Dental & Vision insurances; FSA, DCARE, Commuter Benefits; Supplemental Life, Hospital, Critical Illness and Legal Insurance; Health Savings Account; 401(k) Retirement Plan (Employer Matching benefit); Paid Time Off (Rollover Option) and Holidays; As Needed Sick Time; Tuition Reimbursement; Team Social Activities (We have fun!); Employee Recognition; Employee Referral Program; Paid Parental Leave and Bereavement