Analytical Instrumentation Specialist

You Matter to Cambrex.

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 more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Responsible for ensuring all laboratory instrumentation and associated software systems are in a state of regulatory compliance and readiness. Maintain system for tracking equipment on site, and coordinate with vendors or internal resources to perform maintenance, calibration, and repairs on all analytical laboratory equipment.

• Schedule and execute on‑time IQ/OQ, calibration, routine maintenance, and re‑calibration activities of pharmaceutical laboratory equipment in compliance with applicable SOPs while minimizing impact to laboratory activities and manufacturing. Proactively communicate timelines and maintain strict schedules with flexibility in day‑to‑day activities.
• Strong ability to effectively manage and organize multiple tasks and responsibilities with simultaneous competing priorities in a high‑paced environment.
• Administer users and conduct standard configuration within instrument software, including rebooting of LAC/E boxes.
• Assist with change control process as needed.
• Perform minor chromatography troubleshooting.
• Maintain inventory to ensure adequate parts and supplies are in stock; complete requisitions for equipment and parts as needed.
• Act as escort for approved vendors performing required external calibration and review calibration notebooks per applicable SOPs.
• Promote and provide excellent customer service and support. Maintain a positive relationship with all members of CHP while promoting a positive team environment.
• Comply with Good Manufacturing Practices (GMP) and follow company policies and safety regulations.

• Promote teamwork by working collaboratively with colleagues for the good of the business overall.
• Proven capability to focus on delivering excellent results.
• Ability to recognize opportunities and issues and apply analytical and creative thinking to maximize performance.
• Strong customer service focus and ability to effectively interact with all levels of employees.

• BA/BS in chemistry, life sciences, metrology, or related engineering or science discipline (or equivalent) plus minimum 5 years of experience in FDA‑regulated pharmaceutical manufacturing industry, with minimum 2 years hands‑on laboratory experience in equipment calibration/qualification.
• Experience in Quality System/Pharmaceuticals, planning maintenance and/or calibration activities, and investigating OOT results is a plus.
• Some knowledge of Agilent Chem Station/Open Lab and Waters Empower.
• Basic knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
• Basic knowledge and experience in the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems.
• Basic knowledge of metrology practices and theories and understanding of industrial instrumentation and measurement principles.
• Good troubleshooting and problem‑solving skills; ability to analyze and diagnose instrument failures rapidly and effectively.
• Excellent verbal and written communication, interpersonal skills, organizational skills, and ability to work in a diverse team environment.
• Proficiency with Microsoft software (Word, Excel, PowerPoint).
• Understanding of technical documents such as URS, SAT, FAT, Validation Protocols.

Sedentary work. The daily work is performed in an office setting as well as the laboratories. Walking and standing are required on a regular basis to interact with colleagues, vendors and work on equipment. Knowledge of working safely with chemicals is required.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on…