Company InformationYou 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 OverviewAs 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 desirabl e
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
The hiring range in Colorado for this position is $85,000/year - $108,000/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.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. 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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Supervision Received: General
Works under general supervision. Relies on experience and judgment to plan and accomplish goals within defined procedures and
practices. Seeks management direction for problems of diverse scope.
Travel: Not applicable
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious place s and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.