Senior Validation Engineer (Chicagoland Area)
PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States, and Ireland, and servicing the Life Sciences, F&B and Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Chicagoland area).
The Senior Validation Engineer will be responsible for the preparation, review, and approval of quality and validation related documentation and ensuring compliance during manufacturing operations. This includes full execution of the System Development Lifecyle (SDLC) for an array of equipment and systems supporting manufacturing, laboratories and/or packaging processes. Specific assignments will vary based on the experience and expertise of the successful candidate, and requirements and expectations of the client.
- Bachelor’s degree in Engineering or Technical discipline
- Minimum of eight (8) years Commissioning, Qualification, and/or Validation experience within technical/regulated industries
- Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV), Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, calibration, etc.)
- Experience with standard industry Process, Packaging, Facilities/Utilities, which may include: Control Box equipment (e.g. PLCs, HMIs, ladder logic, etc.), Packaging Labelers/Cartoners, BMS/CMS Systems (e.g. AHUs, Metasys, NAE controllers, etc.), Lab Equipment (e.g. Homogenizers, Spectrophotometers, Lyophilizers, Balances, Freezers/Coolers, etc.) and Automated in-process Filling, Assembly, and Delivery lines.
- Knowledge and experience with electronic document retention systems for approval, change control, and archiving purposes (i.e. Regulus, SharePoint, The Box, etc.)
- Knowledge of industry CSV and C&Q expectations and requirements (e.g. FDA guidelines, USP, GAMP 5, ISO, etc.)
- Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards
- Ability to lead, manage and execute large product launch/release, small capital projects, and process improvement changes related to the manufacturing systems within the site
Desired Hard Skill Sets:
- Comprehensive understanding of supporting process control systems related documentation (e.g. P&ID’s, electrical drawings, certificates of conformance, etc.)
- CSV experience, specifically around CFR Part 11 Electronic Record and Signatures
- Experience with Data Historian, Migration, and Historian systems (i.e. OSI PI)
- Project Management experience with the ability to lead and drive projects to completion autonomously
Desired Soft Skills:
- Comfortable with 24/7 manufacturing environment
- Works well with others, within a team and takes accountability
- Can handle a high-pressure, high-stress work environment
- Result driven and self-motivated
- Strong interpersonal and communication skills (verbal and presentation)
- Organized, with strong computer literacy such as MS Project, Excel, etc.
Location: Chicago, IL
Travel: Up to 10% of the time to various suppliers, collaborators, and OEM sites outside of Chicago, IL.
Competitive Salary and Benefits Package