Job Title:
Lead Engineer for Commissioning and Qualification
Essential Duties and Responsibilities:
* Plan and lead a team of engineers in commissioning and qualifying CIP systems.
* Oversee the completion of hydraulic balancing of CIP systems.
* Liaise with other system owners to coordinate CIP testing activities and ensure timely completion.
* Participate in design document reviews to guarantee quality aspects are incorporated.
* Attend Factory Acceptance Tests (FAT) and execute agreed-upon testing protocols, sign off on permission to ship forms.
* Generate CQV documents at project level and for specific equipment/systems, coordinating with Quality, Engineering, and CQV teams.
* Collaborate with automation teams to ensure process descriptions are provided and functional specs are reviewed and approved.
* Track and confirm closure of action items identified during FAT, HAZOP, Design Qualification, and other reviews.
* Maintain strong communication with Automation and Engineering teams to resolve issues promptly.
* Participate in construction system completion walkdowns.
* Coordinate and lead shift C&Q engineers in executing commissioning, cycle development, and shakedown activities.
* Perform shakedown and commissioning of systems.
* Introduce caustic to CIP skids and oversee safe usage of caustic in cleaning cycle development.
* Oversee cycle development to reduce caustic concentration to acceptable levels.
Requirements:
* Bachelor's degree in an engineering discipline, preferably mechanical or process engineering.
* Extensive experience from biotechnology or pharmaceutical GMP manufacturing/CQV environments.
* Proven expertise in commissioning and qualifying CIP systems.
* Experience in leading teams of engineers.
* Demonstrated ability to work independently and respond proactively to business needs.
* Excellent interpersonal and communication skills.
* Familiarity with Delta-V & Navis Works is advantageous.