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
Qualifications:
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
The hiring range in Colorado for this position is $80,000/year - $100,000/year; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data.
This information is provided per the Colorado Equal Pay Act.
This position includes a competitive benefits package.
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.
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