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 2,000 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 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

Under general supervision of the Supervisor, operates and set up the equipment used in processing chemicals and pharmaceutical products t to complete the successful manufacture of qualified product.

Responsibilities

The WC 35/38/51 operator duties include but are not limited to the following:

• Operate batch type reactors, centrifuges, filters, dryers, isolators, mills, micronizers and other supporting equipment involved in production of products in the WC 35/38/51 equipment/suites, all according to designated procedures.

• Be able to work using isolators and/or glove bags as needed for processing and sampling.

• Work with High Potency equipment / processes as needed including kilo lab equipment as necessary.

• Monitor the equipment; setting controls on valves, vacuums, pumps, pressures, etc., according to designated procedures to achieve desired results.

• Maintains accurate records in the log books of all process equipment.

• Monitors the process variables and makes process control adjustments to maintain the proper process control. Use manual and computer controlled devices to monitor and control the process.

• Clean all equipment used (boil, scrape or scrub out) following designated procedures.

• Assist in training new WC35/38/51 Operators or others assigned to assist with production in the work centers.

• Drum compounds and hazardous waste; label according to set standards; transport to assigned areas.

• Assure area is kept clean and all precautions are taken to prevent environmental spills and control discharge to WWTP at acceptable limits.

• Complete environmental monitoring samples for all work centers

• Interpret results and monitor processes using computer controlled devices.

• Troubleshoot production line and equipment problems in a safe and effective manner. Including performing minor maintenance and preventive maintenance as needed.

• Complete line entry, confined space, and hot work permits.

• Assist in writing and updating process procedures and SOP’s.

• Adhere to all EPA, DEA, FDA and cGMP regulations as they relate to the operation of the manufacturing facility.

• Take samples for in-process and Quality Control analysis.

• Assist with kilo lab duties as assigned

• Perform laboratory tests on process samples and act on results.

• Operators will be required to gown in full personal protective equipment, including respirators and Tyvek suits.

• Operators will need to use isolators and flexible containment.

• Other activities relating to assigned departmental mission not specifically detailed in this section.

  "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

• High School Diploma or Equivalent

• Basic computer operation or automated control systems knowledge.

• DEA background check required

• Respirator use required

• Standing and Walking - Operators stand for long periods and may also do a considerable amount of walking

• Lifting and Handling This role may require lfiting and handling of raw materialls and equipment as much as 50 ilbs.

• This job requires use of proper PPE, including but not limited to Steel toe shoes, safety glasses, and fire-retardant clothing.

• Shift assignment may vary . Must be able to work nights and/or every other weekend as per shift assignment

  All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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