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.

PURPOSE OF THE POSITION :

To carry out the activities related to CPL's Validation Program ensuring that these activities meet current GMP / cGMP requirements.

SPECIFIC RESPONSIBILITIES :

• Responsible for working in compliance with established safe work practices and procedures;
• Develop and execute process and cleaning validation protocols, ensuring compliance with regulatory requirements and industry standards.
• Participate in the design and development of cleaning and process validation studies for new and existing products and processes.
• Collaborate closely with cross-functional (such as Production Operations, Process Engineering, Maintenance, Quality, Account Management, and other relevant departments) teams to understand project requirements and objectives to ensure prompt execution of validation studies.
• Independently manage validation projects, adhering to established timelines and milestones.
• Create protocols and amendments for cleaning and process validation and generate comprehensive summary reports in accordance with GMPs and CPL's Validation Master Plan.
• Execute protocols for cleaning validation / re-validation and / or provide training to personnel responsible for these operations.
• Evaluate and interpret results obtained from validation studies to determine process consistency and capability to meet expected requirements and generate comprehensive summary reports.
• 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.
• Perform risk assessments to determine impact of proposed changes to validated processes.
• Perform updates to the Validation Master Plan.
• Develop and maintain Standard Operating Procedures (SOPs) pertinent to the Validation Program.
• Manage swabbing activities to ensure they do not impact the production schedule.
• Identify and troubleshoot issues that may arise during the validation process, proposing and implementing effective solutions.
• Maintain accurate and detailed documentation of validation activities.
• Communicate effectively with stakeholders to provide updates on validation progress and results.
• Participate in continuous improvement initiatives to enhance validation processes and procedures.
• Other duties as assigned.

QUALIFICATIONS :

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.