Validation Specialist
5 months ago
**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**:
- Bachelor's degree in a relevant scientific or engineering field (preferred: Bachelor's Degree in Engineering
- chemical, mechanical or equivalent.
- Strong understanding of Pharmaceutical Manufacturing and Packaging, GMP and cGMP.
- Proven experience in technical writing, protocol development, data analysis, and report generation, preferably in a validation or regulated environment. Minimum of 1 - 3 years of validation experience in developing, writing and executing validation plans, protocols and reports.
- Familiarity with regulatory requirements such as FDA, cGMP, or ISO standards is preferred.
- Commitment to adhering to safety protocols and practices in a laboratory or manufacturing setting.
- Excellent verbal and written English communication skills.
- Effective communication skills with the ability to interact across various levels of the organization.
- Capable of writing validation documentation with mínimal supervision.
- Computer literacy is required with a strong emphasis on MS Word and Excel. Preferred: Working knowledge of Minitab, MS Project and Visio.
- Exceptional organizational skills with acute attention to detail and accuracy.
- Strong problem-solving abilities and time management skills to ensure timely completion of tasks.
- Excellent problem-solving skills and attention to detail.
- Proficiency in using analytical tools and software for data analysis. Preferred: Basic understanding of statistical methods (standard deviation, process capabilities, etc.)
- Ability and proficient in handling and analyzing data, deriving conclusions, and making recommendations based on results using sound engineering and
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