Lead CQV Engineer (Filling & Packing Line SME)

at  Genesis AEC

EXPERIENCED COMMISSIONING QUALIFICATION & VALIDATION (CQV) ENGINEER WITH FILLING & PACKING LINE SUBJECT MATTER EXPERTISE (SME)

Do you have a meticulous eye for detail? Are you looking for a career that will leverage this and your outstanding ability to build meaningful relationships? If so, we are looking for you to join our exceptional team as an experienced CQV Engineer!

WHO WE ARE

We’re Genesis AEC – an award-winning architecture, engineering, construction management, and CQV firm and a leader in the life sciences industry. Ranked #5 in Pharmaceutical Design by ENR magazine, we are designing and constructing facilities that advance worldwide health. We’re proud to contribute to our Client’s success, earning honors that include a 2021 ISPE Facility of the Year (FOYA) award and an ENR Mid-Atlantic’s Best Manufacturing Project award for our work at the National Institutes of Health.
Our culture is based on inclusion, one where all identities, backgrounds, and perspectives are embraced. When you’re on our team, you’ll find you are supported, challenged, and encouraged to grow – with opportunities, training, and a work-life balance to help you succeed.

YOU MAY BE A GOOD FIT IF YOU MEET THESE REQUIREMENTS:

The selected Lead Validation/CQV Engineer will have subject matter expertise (SME) in the following skills:

• Sterile Filling Lines
• Sterile Packaging Lines
• Sterile filling Systems (RABS, and isolators)

Additionally, the selected candidate may also have experience in some or all the following areas (ideally, but not required):

Typical duties required, but not limited to:

• Reads and understands technical documentation (drawings, diagrams, product data, functional descriptions, etc.)
• Develops test protocols utilizing client standards, vendor, and design documentation.
• Develops test scripts (not just handed a template to re-use).
• Coordinates with the owner daily to develop and execute documents.
• Coordinates and leads other CQV Engineers in a project team environment.
• Oversees and drafts Commissioning and IOPQ protocols.
• Performs CQV execution as required.
• Manages work scope against our proposal and identifies additional work scope in change orders.
• Tracks and manages the project schedule.
• Reviews project financials with internal management and external clients.
• Tracks budgets and manages work to meet those budgets.
• Tracks and resolves issues with the owner.
• Develops summary reports