Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sr Associate Laboratory Operations

Responsibilities:

Responsible for the validation of laboratory instruments/equipment and be able to provide hands-on training, execution, operation, and sustainment of Process Development (PD) laboratory operations. This role has specific accountability for the general PD laboratory spaces, challenge kits, and preliminary diagnostic capabilities that support manufacturing and development activities.

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.

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.

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.

• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

#LI-MV1