Cleaning Validation Specialist

Cencora • Puerto Rico, TX

3d • Onsite

About The Position

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.

Requirements

• Strong understanding of GMPs and global regulatory expectations.
• Ability to interpret equipment design, P&IDs, and process flow diagrams.
• Excellent technical writing and documentation skills.
• Strong analytical and problem solving abilities.
• Effective communication and cross-functional collaboration.
• Ability to work independently and manage multiple priorities.
• Proficient with KNEAT

Nice To Haves

• Minimum of 5 years of professional experience in cleaning validation in the pharmaceutical and biotechnology industries.
• Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
• Validation Sample Management lifecycle experience
• Strong project management skills.
• Proficient time management skills, planning and organization capabilities.
• Proven leadership & teamwork skills, self-starter, results oriented and build and maintain strong relationships with multiple groups.
• Proficiency in Risk Assessment/Management
• Proven assessment, analytical and problem-solving skills.
• Proficient presentation skills and Technical Writing/Oral communication skills (English)
• Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.

Responsibilities

• Coordinate cleaning validation activities.
• Prepare and execute protocols and reports for cleaning development and validation.
• Perform investigation of deviations / discrepancies.
• Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies
• Supports non-traditional work schedule based on project and business needs
• Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
• Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
• Leads and performs on floor CV execution and sampling.
• Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Proficient with KNEAT execution
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
• Supports the periodic review of cleaning validation studies.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.

Benefits

• medical, dental, and vision care
• comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
• variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level