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

As part of the Cambrex ESDT Validation Team, this role coordinates and supports validation and qualification activities related to the manufacturing and analytical equipment; provides on the floor execution support, tracking, and updates. Provide technical expertise to ensure equipment, utility and facility systems are in compliance with company validation guidelines and cGMP regulations.

Responsibilities

• Responsible for validating and qualifying GMP analytical instruments, equipment, utilities, and facilities
• Develop and/or execute qualification and validation (IQ, OQ, PQ) documentation and ensure they are written in accordance with Cambrex Corporate Policies and industry standards
• Develop Validation Plans, Validation Plan Summary Reports, Annual Validation Plans, and Annual Validation Review reports
• Clearly and accurately document activities across the validation life cycle as requested
• Assist with developing specifications as needed for equipment / systems
• Collaborate with Manufacturing, Quality Control, Facilities, IT, and Materials Management in the implementation of validation activities
• Work closely with equipment vendors to ensure thorough and accurate documentation is gathered during qualification processes
• Remain current in industry best practices and regulatory guidance
• Provide validation support for client and regulatory audits
• Adhere to all site safety procedures and guidelines

Qualifications/Skills

• Ability to work independently and work as part of a large cross-functional group
• Ability to organize and prioritize work in order to meet established timeframes and schedules
• Ability to learn how equipment functions and then design appropriate validation / qualification protocols
• Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action
• Basic understanding of pharmaceutical manufacturing and analytical equipment and processes
• Understanding of the basic principles of validation spanning the entire equipment lifecycle
• Must have strong organization, interpersonal, oral, and written communication skills
• Knowledgeable in enterprise systems including Blue Mountain Regulatory Asset Management System, Rees Environmental Monitoring System, and Master Control Document Management System is desirable

Education, Experience & Licensing Requirements

• A Bachelor’s Degree or higher in a scientific discipline is required
• 3-5+ years of experience in a GMP pharmaceutical environment working with the validation and qualification of equipment, utility, and/or facility systems