Company Information

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 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

Job Overview

Ensure all laboratory instrumentation and software systems are in a state of regulatory compliance and readiness.

Responsibilities

• Plan, schedule, and monitor laboratory needs to ensure instrumentation is available to support on time testing and delivery.
• Perform routine instrument preventive maintenance (PM), Calibration (Cal), and Qualification (Qual.) on instruments according to established procedures.
• Maintain the schedule for instrumentation PM, Cal, and Qual. activities.
• Perform routine and advanced troubleshooting and repair of laboratory instruments.
• Review documentation associated with instrument PM, Cal, and Qual. events.
• Recommend changes to established instrument procedures to improve efficiency while maintaining compliance.
• Create, maintain, and update documentation and Standard Operating Procedures relating to instrumentation.
• Administer users and conduct standard configuration within instrument software.
• Work closely with MIS personnel during performance of job responsibilities.
• Coordinate service providers to schedule work. Facilitate communication and provide information regarding instrumentation issues or service. Manage service contracts.
• Maintain instrument parts inventory system.
• Provide assistance with internal and external audits.
• Participate in a scheduled On-Call rotation covering off-hours support of the facility.

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications/Skills

• Chemistry bachelor’s degree or equivalent specialized laboratory experience required. Experience in a contract API manufacturing environment a plus.
• Ability to work in a fast-paced highly independent and self-directed work environment.
• Strong written and verbal communication skills to aide in communicating with peers, internal customers, vendors, and in documentation and procedures.
• Familiarity GMP regulations is required. Prior experience in a GMP analytical laboratory is preferred. Experience with GAMP a plus.
• Functional understanding of laboratory instrumentation and computer validation (IQ/OQ/PQ).
• 3 or more years of experience supporting, repairing, troubleshooting, and maintaining various analytical instruments. Prior experience with Waters UPLC, Agilent HPLC and Agilent GC equipment will be given preferential consideration.
• Hands on operational knowledge of analytical instrumentation like UPLC, HPLC, GC, FT-IR, UV-VIS, DSC, ICP, and titration equipment.
• Experience with analytical software systems like Waters Empower, Mettler-Toledo LabX, and others. Administrative knowledge a plus.
• Understanding of basic networking, client-server architectures, and Windows workstation and server operating systems.
• Skills in basic mathematics and statistical calculations.
• Demonstrated computer software literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment.

Education, Experience & Licensing Requirements

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Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.