Senior Validation Specialist

Job Responsibility: WHO WE ARE: At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products. For more than 30 years CPL has partnered with the world's leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency. We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee's assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program. ABOUT THE OPPORTUNITY: The ideal candidate will take a leadership role in the design and development of cross-contamination quality systems, cleaning validation programs, and process validation studies for both new and existing products and processes. This role will involve conducting risk assessments, leading segregation plans, and ensuring compliance with regulatory requirements. The Senior Validation Specialist should possess exceptional technical writing skills, be adept at creating protocols, analyzing data, and generating comprehensive summary reports. They must exhibit strong organizational abilities, a commitment to meeting deadlines with precision, excellent problem-solving skills, and effective time management. The role requires the ability to primarily work independently while fostering collaborative relationships with Operations, Quality, Lab, Project Managers, Engineering, and Product Development teams.

SPECIFIC RESPONSIBILITIES :

• Lead and participate in the design and development of cross-contamination quality systems, including segregation plans and risk assessments.
• Perform comprehensive risk assessments to evaluate the segregation plans in a multi-product facility.
• Spearhead the creation and enhancement of cleaning validation programs for new and existing products and processes.
• Lead and participate in the design and development of process validation studies for new and existing products and processes.
• Conduct and oversee cleaning and process validation studies, ensuring compliance with regulatory standards and industry best practices.
• Perform comprehensive risk assessments to evaluate the impact of proposed changes to validated processes.
• Update and maintain the Validation Master Plan in accordance with evolving regulatory requirements and organizational needs.
• Develop, review, and finalize validation protocols, ensuring accuracy, completeness, and compliance with established standards in accordance with GMPS and CPL's Validation Master Plan
• Analyze validation data, interpret results, and prepare detailed summary reports for stakeholders.
• Collaborate effectively with cross-functional teams, including Operations, Quality, Lab, Project Managers, Engineering, and Product Development, to achieve validation objectives.
• Liaise with CPL customers regarding joint validation projects and activities.
• Update and maintain the Validation Master Plan in accordance with evolving regulatory requirements and organizational needs.
• Independently manage validation projects, adhering to established timelines and milestones.
• Execute protocols for cleaning validation/re-validation and/or provide training to personnel responsible for these operations.
• Identify and recommend enhancements to validation strategies and procedures to optimize efficiency and compliance.
• Conduct and document cleaning assessments to identify new worst-case products for cleaning validation.
• Maintain and update the Cleaning Validation Risk Assessment as needed.
• Develop and maintain Standard Operating Procedures (SOPs) pertinent to the Validation Program.
• Identify and troubleshoot issues that may arise during the validation process, proposing and implementing effective solutions.
• Provide guidance, mentorship, and support to junior team members as needed.
• Communicate effectively with stakeholders to provide updates on validation progress and results.
• Participate in continuous improvement initiatives to enhance validation processes and procedures.

QUALIFICATIONS:

• Bachelor's or Master's degree in a relevant scientific or engineering field (or equivalent work experience).
• Extensive experience (5+ years) in leading and participating in the design and development of cross-contamination quality systems, cleaning validation programs, and process validation studies within a regulated industry.
• Strong proficiency in technical writing, protocol development, data analysis, and report generation related to validation activities.
• Excellent organizational skills with a proven ability to manage multiple projects concurrently.
• Exceptional problem-solving capabilities and meticulous attention to detail.
• Proven time management skills and the ability to work both independently and collaboratively within a team environment.
• Effective communication skills to liaise across different departments, levels of the organization and clients.
• In-depth knowledge of regulatory requirements (HC HPFBI, FDA, GMP/cGMP, etc.) pertaining to validation processes.
• Demonstrated leadership abilities and experience mentoring or guiding junior team members is advantageous.

CPL is an equal-opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us.

• We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.