Cleaning Validation Specialist

PharmaLex; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

PharmaLex is seeking a Cleaning Validation Specialist in Juncos, Puerto Rico. The role involves coordinating cleaning validation activities, preparing protocols, and performing investigations on deviations.

Candidates should have a Bachelor's in science, Pharmacy or Engineering and a minimum of 5 years in cleaning validation. Skills in project management, communication, and technical writing are necessary for success.

Join us to help maintain high standards in pharmaceutical processes and ensure a clean environment for product development.

Qualifications

• Minimum of 5 years in cleaning validation in pharmaceutical/biotechnology.
• Proficient in cleaning validation and continuous process improvement.
• Strong leadership, teamwork, and project management skills.

Responsibilities

• Coordinate cleaning validation activities and execute protocols.
• Investigate deviations and support technical documentation.
• Collaborate with Quality Assurance and Engineering teams.

Skills

GMP understanding

Technical writing

Analytical skills

Project management

Communication skills

KNEAT proficiency

Education

Bachelor's in science, Pharmacy or Engineering

Tools

KNEAT

Job description

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!

Summary of Role

Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.

Responsibilities

• 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-administrative hours, based on project needs.

Location

Carolina, PR / Juncos, PR

Education

Bachelor’s in science, Pharmacy or Engineering

Preferred Qualifications

• 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.

Skills

• 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.

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. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request‑by‑request basis.

Affiliated Companies

Affiliated Companies: Echo Consulting Group Inc