: 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:

The Technician Calibration is responsible for performing calibration activities at the Cambrex Whippany site. Calibration of laboratory instruments is excluded. Responsibilities include execution of scheduled and non-scheduled calibration of all GMP devices such as gauges, transmitters, scales, sensors, etc. on equipment and/or systems within plant and manufacturing operations. These calibration points are located in aseptic manufacturing, liquids manufacturing, solid dose manufacturing, product packaging, central utilities area, and de-centralized equipment located in various technical spaces within the site. The incumbent will be expected to become the site subject matter expert on the calibration of these devices, and will interact with Production, Packaging, QC, QA, Technical services, Maintenance, IT, Materials Management, Product Development and other departments as required.

Responsibilities:

The technician will utilize calibrated/certified test equipment to perform all calibrations. Generated data and associated documents will be required information to support calibration activities. Technician will receive job assignments from the Specialist, Calibration position. All Calibration activities and results will comply with cGMPs and good documentation practices. The technician will:

• Ensure that current calibrated/certified test instrumentation is utilized for all calibration activities.
• Ensure that good documentation practices are employed during data and record generation.
• Communicate to the Specialist, Calibration whenever issues are encountered during calibration activities.
• Adhere to approved department SOPs governing the site’s calibration program.
• Work in GMP areas of the site and adhere to current gowning and PPE requirements.
• Assist the Specialist, Calibration to source replacements for defective components/devices discovered during calibration activities.
• Communicate effectively with site department supervision.
• Look for opportunities to improve compliance and reduce costs.

• Adhere to cGMPs, SOPs and site safety policies.
• Based upon device availability, must be available to work alternates shifts as required.
• Perform other duties as assigned.

Qualifications:

• Must be technically sound.
• Must be familiar with typical calibration test equipment and their use.
• Must have a good working knowledge of current, voltage, power and pressure units of measure.
• Demonstrate effective communicating and interpersonal skills
• Previous experience working in a GMP environment desired
• Must be able to manipulate and draw conclusions from collected data.
• Must be able to move about the facility
• Must be able to remain in an upright position
• Must be able to remain sedentary for a period of time
• May be required to lift and carry equipment
• May be required to be in confined spaces
• Required to wear personal protective equipment

EDUCATION:

• High School diploma or equivalent.

EXPERIENCE: