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 2,400 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 medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., 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

This position is responsible for developing and implementing complex validation processes to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Creates and reviews validation processes and procedures, making recommendations for changes and/or improvements. Based on significant technical expertise, will develop strategy and drive implementation; authors, reviews and approves complex validation programs; and mentors junior validation specialists in validation concepts and industry guidelines.

Responsibilities

• Responsible for development, execution and successful completion of process performance qualification (PPQ), packaging and cleaning validation activities for pharmaceutical oral dosage forms.
• Duties including development of project risk evaluations, batch strategy and sample plan implementation justifications.
• Author and approve Validation protocols, Validation Project Plans and Validation Summary Packages.
• Responsible for the coordination of supportive validation activities (such as shop floor scheduling, laboratory testing, calibration and engineering studies) and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.
• Responsibilities also include performing technical failure analysis of processes/product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product/process variability.
• Applies statistical analysis to validation data using statistical program software to determine process capabilities and recommendations for process improvements.
• Develop and execute ancillary studies to support product compliance and capability such as hold time studies and shipping studies.
• Participate in developing Divisional procedures and guidelines

Education, Experience & Licensing Requirements

• Requires excellent analytical skills with systematic approaches to problem solving. Also must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word and Excel, JMP statistical computer software.
• Ability to function as Validation team lead on cross functional project teams.
• Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines.
• Knowledge of GMPs, FDA guidelines, and process validation.
• Ability to design and influence outside of immediate scope of responsibility.
• Proven track record of leadership effectiveness.
• May be required to move about the facility
• May be required to wear personal protective equipment
• May be required to remain sedentary for periods of time