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.
Shift: Administrative shift and willing to provide services during non admin. hours, based on project needs
Location: Carolina, PR / Juncos, PR
Education: Bachelor's in science,Pharmacy or Engineering
Requirements
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.
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
This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
What Cencora offers
Full time
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued su
Benefits
Health insuranceDental insuranceVision insuranceParental leave
Additional Information
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!
Job Details
Summary of Role:
Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.
Myhrabc · Juncos, PR