Cleaning Validation Specialist

Cencora•Puerto Rico, TX

2d•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! 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. 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 We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses 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. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora 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 success depends on the full and effective utilization of qualified individuals. Therefore, 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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health. Recruitment scams are on the rise and the intent is to target individuals looking for employment opportunities. To protect yourself, we urge you to be vigilant and follow these guidelines. 1.) Research the Company: Thoroughly research any company before applying or sharing personal information, check their website, read reviews, and verify their legitimacy. 2.) Be Wary of Unrealistic Promises: Exercise caution If a job posting offers high salaries and minimal qualifications. Legitimate jobs will have realistic expectations and provide detailed job requirements. Jobs at Cencora can be found on Cencora.com/careers 3.) Guard Your Personal Information: Only share sensitive information after vetting the employer’s credibility. Avoid sharing your Social Security number, bank account details, or identification documents during the application process. Cencora does not request this information as part of the employment application. 4.) Avoid Upfront Payments: Legitimate employers do not require payment during the hiring process. Be suspicious if you are asked to pay for training materials, processing fees, or background checks before securing a job offer. Cencora will never ask you for payment information during the hiring or onboarding process. 5.) Verify Communication Channels: Scammers often use free email services or chat platforms without providing an official company contact information. Cencora recruiters will have an email address ending in @cencora.com, @alliance-healthcare.net, @alliance-healthcare.co.uk, alliance-healthcare.fr or alliance-healthcare.ro Remember to stay vigilant and informed about common scam tactics to reduce the risk of falling victim to fraudulent employment schemes. If you believe you have encountered a job scam posing as a Cencora opportunity, please report it immediately to: [email protected]

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
Bachelor’s in science,Pharmacy or Engineering

Nice To Haves

8 plus years in pharmaceutical industry with hands on Cleaning Validation experience.
Proficient execution experience in Kneat
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

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.