Validation Engineer

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

We are seeking a highly skilled Calibration Specialist to join our consulting team. The Calibration Specialist will play a crucial role in calibrating instruments and setting up calibration processes for our clients in the pharmaceutical, biotechnology, and medical device industries. The ideal candidate will possess strong technical expertise, communication skills, and a thorough understanding of regulatory requirements.

Key Responsibilities:

• Perform calibrations following written calibration procedures.
• Accurately complete calibration paperwork, including work orders and logbooks in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health, and safety requirements.
• Perform calibration activities on all types of instrumentation, which include: pressure gauges, controllers, recorders and switches, temperature recorders, switches, controllers and indicators, resistivity meters, recorders and controllers, timers, flow, speed and electrical devices, Gauge blocks, Go/No-Go gauges, calipers, Humidity probes.
• Maintain calibration documentation that demonstrates each instrument’s NIST Traceability.
• Maintain and troubleshoot facility standalone instrumentation and control systems.
• Review and update calibration procedures based on field experience.
• Identify opportunities for improving Calibration program.
• Respond to customer requests and/or alarm conditions.
• Assess instrument failures/breakdowns, systematically identify problems, and restore to operation.
• Accurately document repair activities.
• Responsible for calibration data entry and maintaining calibration database.
• Responsible for maintaining calibration lab.
• Responsible for sending instruments out to vendors as well a scheduling contractors to come on-site for scheduled and/or on demand calibrations.
• Support and assist in the execution of validation activities, which include:
• Controlled storage: temperature distribution qualification.
• Maintenance validation: autoclaves, depyrogenation tunnels, automated visual inspection equipment.
• Equipment validations as required.
• Support Quality Assurance investigations of instrument failures/breakdowns.
• Perform any other tasks/duties as assigned by management.

Requirements

• BS in Engineering, Science or equivalent technical degree.
• 2-5 years experience with calibration and metrology in a GMP environment.
• BMRAM or other calibration software experience preferred.
• Solid understanding of GMP regulations and industry standards.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a dynamic team environment.
• Strong analytical and problem-solving skills with attention to detail.
• Understand and translate requestor’s strategies into plans, and be able to drive the project to completion

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Employee must be able to occasionally lift and / or move up to 50 pounds.
• Employee must be able to move various calibration equipment and tools.
• Employee must be able to occasionally sit, kneel or stand for extended times.
• Employee must be able to occasionally crawl, climb, bend or squat

Benefits

What We Offer:

Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.

Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.

Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.