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