: Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Overview:

This role will support scheduling, tracking, and performance of work for the Metrology, Facilities, Validation, and Analytical Laboratory groups. The position will facilitate the accurate and timely scheduling and/or execution of scheduled and on-demand instrument/equipment work events, as well as on-boarding of new equipment, processing requests for change, and managing any deviations (OOTs).

Responsibilities:

• Enter calibration, maintenance and/or validation events into the calibration database in an accurate and timely manner (with strong attention to detail) - Maintain calibration database for real-time accuracy
• Coordinate equipment (new and existing) coming into the Metrology department to ensure timely completion of work
• Obtain service quotes and scheduling offsite/onsite vendor calibrations
• Provide support/guidance to business owners regarding on-boarding of new equipment into the calibration management system database
• Generate required documentation for new and existing instruments
• Review vendor calibration documentation and events
• Enter deviations / Out of Tolerance events (OOTs) into the deviation management system
• Effectively demonstrate an understanding of cGMPs & how they apply to job-specific responsibilities
• Assist in execution of PM / OQs for analytical systems
• Follow accurate oral and written procedures in performance of departmental tasks
• Train and become proficient in calibration and troubleshooting disciplines
• Stay up to date on required training for all procedures associated with the position

• Remain current in industry best practices and regulatory guidance

• Adhere to all site safety procedures and guidelines

Qualifications:

• Associate degree in Engineering, Life Sciences, other related technical field or equivalent military training (PMEL etc.) and 2-5 years of applicable (Metrology, Instrumentation, Calibration) experience or the equivalent combination of education and experience.
• Previous experience maintaining Metrology and/or Quality documentation management systems (Note: Previous experience working with Blue Mountain Regulatory Asset Manager (BMRAM) or similar Metrology maintenance and tracking software systems is highly desired for this position)
• Previous experience working in a cGMP or similar highly regulated industry with a functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with all associated Quality regulations and guidelines

• Basic understanding of pharmaceutical manufacturing and analytical equipment and processes
• Understanding of the basic principles of metrology spanning the entire equipment lifecycle

• Ability to organize and prioritize work to meet established timeframes and schedules
• Candidate must be a self-starter, motivated and productive, with very strong attention to detail
• Experience working in a team environment; with excellent communication and organizational skills
• Strong Math, Reading, Writing and Analytical thinking skills are necessary
• Experience working with Microsoft Word, Excel and Outlook
• Ability to recognize problems and recommend solutions to problems
• Ability to understand and work within the Quality Management System (QMS)