Company Information
You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
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
The Manager, Cleaning Validation is responsible for leading and maintaining the cleaning validation program at Cambrex Charles City in support of active pharmaceutical ingredient (API) manufacturing operations. This role serves as the site subject matter expert for cleaning validation and cleaning verification, ensuring equipment and cleaning processes are appropriately designed, validated, documented, and maintained in accordance with current Good Manufacturing Practices (cGMP), regulatory expectations, and Cambrex procedures. The manager provides technical and people leadership, supports regulatory inspection readiness, and partners across Manufacturing, Engineering, Quality Assurance, Quality Control, Analytical Development, Process Development, and Technical Services to implement scientifically sound, risk-based cleaning validation strategies.
Reports to: Director or Associate Director, Engineering / Validation
Direct Reports: Validation professionals and/or contract resources, as assigned
Role Type: First-line people manager with active technical and project responsibilities
Responsibilities
Leadership and People Management
Directly supervise, coach, and develop validation professionals and/or contractors supporting cleaning validation activities, as applicable.
Establish priorities, assign work, monitor progress, and ensure cleaning validation commitments are completed safely, compliantly, and on schedule.
Set performance expectations, support employee development, and provide technical guidance and training.
Communicate validation risks, project status, resource needs, and significant compliance or scheduling issues to site leadership.
Promote a culture of safety, accountability, collaboration, technical excellence, and continuous improvement.
Cleaning Validation Program Leadership
Serve as the site subject matter expert for cleaning validation and cleaning verification activities.
Develop, implement, maintain, and continuously improve the site cleaning validation program, policies, procedures, templates, and standards.
Establish scientifically sound, risk-based validation strategies for manufacturing equipment, processes, products, and facilities.
Develop approaches for equipment grouping, product grouping, worst-case selection, sampling strategy, acceptance criteria, clean and dirty hold times, campaign length, and ongoing verification requirements.
Evaluate new products, processes, equipment, cleaning agents, and process changes to determine cleaning validation requirements before GMP implementation.
Ensure cleaning validation activities are integrated with change control, deviation, CAPA, equipment qualification, process validation, and the overall validation lifecycle.
Validation Execution and Documentation
Lead the preparation, execution, review, and approval of cleaning validation master plans, protocols, studies, technical assessments, and final reports.
Ensure validation documentation is accurate, complete, scientifically justified, and compliant with cGMP requirements and Cambrex procedures.
Partner with Analytical Development and Quality Control on analytical methods used to identify and quantify residues from API manufacturing processes.
Establish acceptance limits and sampling plans based on toxicological or health-based exposure limits, product characteristics, process knowledge, equipment design, analytical capability, and regulatory expectations.
Assess manufacturing procedures, equipment configurations, cleaning instructions, analytical methods, and process changes for impact to validated cleaning processes.
Maintain lifecycle documentation and ensure validated status is preserved following equipment, product, process, or cleaning procedure changes.
Technical Leadership and Risk Management
Lead quality risk assessments and gap analyses related to cleaning processes and validation requirements.
Investigate deviations, failures, atypical results, and adverse trends; determine root cause and ensure appropriate corrective and preventive actions are implemented.
Provide technical expertise regarding equipment cleanability, hard-to-clean locations, sampling locations, cleaning parameters, residue limits, process controls, and validation strategy.
Use data and trend analysis to confirm the continued effectiveness and state of control of validated cleaning processes.
Identify opportunities to standardize cleaning approaches, reduce compliance risk, and improve validation efficiency without compromising product quality or patient safety.
Cross-Functional, Regulatory, and Compliance Support
Partner with Manufacturing, Engineering, Quality Assurance, Quality Control, Analytical Development, Process Development, EHS, and Technical Services to execute validation activities.
Provide cleaning validation input for equipment design, modification, commissioning, qualification, technology transfer, new product introduction, and manufacturing process changes.
Support project teams and manufacturing schedules by coordinating validation scope, resources, timelines, and required documentation.
Ensure cleaning validation activities comply with cGMP, data integrity expectations, site procedures, and applicable FDA, ICH, and other regulatory requirements.
Support customer audits and regulatory inspections as the cleaning validation subject matter expert, including presentation of technical rationale and documentation.
Lead or support responses and remediation associated with validation-related audit findings or regulatory observations.
Maintain inspection readiness of cleaning validation records, procedures, and program governance.
Qualifications/Skills
- Strong technical knowledge of cleaning validation, cleaning verification, and validation lifecycle management in pharmaceutical or API manufacturing.
- Knowledge of cGMP requirements, quality risk management, change control, deviation, CAPA, and data integrity principles.
- Understanding of pharmaceutical or chemical equipment cleaning, sampling techniques, residue testing, analytical methods, and health-based exposure limits.
- Strong technical writing, protocol development, investigation, root-cause analysis, and problem-solving skills.
- Demonstrated project management skills and ability to manage multiple priorities and timelines.
- Proven ability to lead cross-functional technical teams and communicate effectively with employees, leaders, customers, and regulatory inspectors.
- Strong attention to detail, sound technical judgment, and commitment to documentation quality and compliance.
Education, Experience & Licensing Requirements
- Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific or technical discipline required; advanced degree preferred.
- Minimum 7 years of relevant experience in pharmaceutical, biopharmaceutical, API, chemical, or other regulated manufacturing environments.
- Minimum 3 years of direct experience with cleaning validation, process validation, equipment validation, or related validation activities, including significant cleaning validation responsibility.
- At least 2 years of experience in a leadership, supervisory, technical lead, or project lead role preferred.
- Experience authoring and executing validation protocols, reports, risk assessments, investigations, and validation strategies required.
- Experience supporting FDA, customer, or other regulatory inspections preferred.
- Experience with API or small-molecule pharmaceutical manufacturing strongly preferred.
Physical Demands, Work Environment, and Travel
Work is performed in office, laboratory, warehouse, mechanical, and pharmaceutical manufacturing environments.
Ability to walk, stand, bend, reach, climb stairs and ladders, and move throughout the manufacturing facility.
Ability to wear required personal protective equipment, including safety glasses, safety shoes, protective clothing, hearing protection, and other PPE as required.
Potential exposure to chemicals, solvents, powders, dust, noise, fumes, odors, moving equipment, and varying temperatures.
Ability to work outside normal business hours when needed to support validation execution, manufacturing schedules, shutdowns, investigations, audits, or inspections.
Occasional travel, generally less than 10% of total work time.
Other Duties
Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.
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.
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
