Senior Engineer - Process Development

Engineer Senior Onsite In this vital role, the Sr Engineer is responsible for the maintaining off line capbailities space within Process Development Department which includes validation of laboratory instruments/equipment and be able to provide hands‑on training, execution, operation, and sustainment laboratory operations. This role has specific accountability for the general PD laboratory spaces, challenge parts/kits, and preliminary diagnostic capabilities that support manufacturing and development activities. This role is a key individual contributor supporting site operations, issue resolution, inspection readiness, and the lifecycle management of validated and compliant laboratory instruments/equipment/systems. The Sr Engineer provides support to Process Development while partnering closely with Manufacturing, Engineering, Quality, and other cross functional departments. Key Responsibilities Validation Leadership & Strategy Lead the validations of laboratory systems, equipment, method transfer, and are commissioned, qualified, and maintained in a validated state. Develop and execute validation strategies aligned with regulatory expectations, corporate standards, and site business objectives. Own or oversee validation governance, including validation plans, lifecycle approaches, and risk‑based strategies for PD Laboratory. Establish and maintain periodic review and ongoing monitoring programs to ensure continued state of control for validated laboratory systems, equipment, and methods. Standards, Challenge Kits & Governance Establish, implement, and maintain laboratory and validation standards, including standardized approaches for qualification, periodic review, and ongoing verification. Oversee the development, qualification, maintenance, and lifecycle management of challenge kits to support equipment qualification, method verification, and manufacturing readiness. Ensure challenge kits and test methods are scientifically sound, fit‑for‑purpose, and consistently applied across PD and manufacturing lines. Lead or support analytical and inspection method transfers to the site, ensuring successful deployment, training, qualification, and sustained compliant use. Ensure alignment with global and site standards while identifying opportunities to simplify, standardize, and improve compliance outcomes. PD Laboratory Operations & Execution Provide ownership of day‑to‑day operation, readiness, and compliant use of PD laboratory spaces and equipment, which include device testing equipment, diagnostic tools, and controlled laboratory spaces. Serve as primary technical owner for assigned PD laboratory systems and equipment. Ensure PD laboratory equipment and diagnostic technologies (e.g., X‑ray inspection systems, Keyence microscopes, and other forensic analysis tools) are qualified, maintained, and used in alignment with intended use and regulatory requirements. Lead and support preliminary assessments of manufacturing component and process issues, partnering with Manufacturing and PD to rapidly identify potential root causes and risk to product quality. Partner with PD and Engineering to support new lab build‑outs, renovations, modifications, technology introductions, and advanced inspection capabilities. Establish and maintain laboratory compliance standards, including expectations for equipment use/inventory, maintenance, documentation, and data integrity. Compliance, Forensic Investigations & Inspection Readiness Ensure laboratory and validation practices align with cGMPs, global regulatory requirements, data integrity expectations, and internal policies. Serve as a primary laboratory and validation contact during regulatory inspections, internal audits, and corporate assessments. Lead or support forensic investigations related to manufacturing deviations, atypical results, and component or equipment‑related failures, including the application of advanced inspection and diagnostic techniques. Ensure timely and compliant resolution of deviations, CAPAs, change controls, risk assessments, and laboratory investigations. Maintain inspection‑ready documentation, systems, and processes at all times. Business Processes & Operational Excellence (OE) Own and continuously improve laboratory and validation business processes, ensuring they are efficient, compliant, and scalable. Drive Operational Excellence (OE) initiatives across PD laboratory operations, validation, and compliance activities. Apply risk‑based, lifecycle, and lean principles to improve execution efficiency while maintaining regulatory compliance. Monitor and trend key performance indicators (KPIs) related to validation execution, laboratory compliance health, periodic review status, and inspection readiness. Leverage data and metrics to identify trends, risks, and improvement opportunities. Cross‑Functional Collaboration Partner with Manufacturing, PD, Engineering, Quality, Facilities & Utilities, and Regulatory to ensure aligned execution of projects and operational priorities. Provide validation, laboratory, and diagnostic capability input into capital projects, tech transfers, and process changes. Represent Validation and PD Laboratory Operations on site and network governance forums as required. Basic Qualifications Master’s degree and/or 2 years in a GMP-regulated environment OR Bachelor’s degree and/or 5 years in a GMP-regulated environment Preferred Qualifications Educational background in Engineering, Life Sciences, or a related technical discipline. Experience with commissioning, qualification, and validation (CQV) of facilities, utilities, equipment, and laboratory systems. Direct Hands‑on experience supporting PD laboratories, laboratory equipment, or validation activities. Experience with advanced inspection, testing, or forensic diagnostic technologies, supporting manufacturing and development operations. Strong knowledge of cGMP regulations, data integrity, laboratory compliance, and validation lifecycle principles. Proven experience leading organizations through regulatory inspections. Demonstrated ability to influence across functions and organizational levels. Strong written and verbal communication skills. Experience driving Operational Excellence, business process improvement, and standardization initiatives. Ability to thrive in a fast‑paced, highly regulated manufacturing and development environment. Pay range is $39 - $44 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience. THE PROMISES WE MAKE: At Crystal Equation, we empower people and advance technology initiatives by building trust. For more information regarding our Privacy Policy, please visit crystalequation.com/privacy. #J-18808-Ljbffr Crystal Equation Corporation