Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols. Write Final summary Reports that summarize executed qualifications/validations. Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry. Coordinate validation related activities in regards to equipment and processes being deployed in GMP environments.
Project Details:
Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations
Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable)
Develop and execute cleaning validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment
Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols
Perform physical testing from representative samples
Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities
Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis
Investigate and resolve deviations/exceptions from the predefined acceptance criteria
Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid
Write Summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies
Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner
Ensure protocols, verification, validation plans and Summary reports generated during validation/ qualification activities are stored according to procedure
Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company
Work proactively to maintain the highest level of compliance in all areas
Gather current knowledge from QA/QC, regulatory, periodicals and/or appropriate training programs
Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D) and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed
Adhere to all cGMPs, compliance/regulatory mandates and quality requirements
Perform other related duties as assigned to meet departmental and Company objectives
Job Experience:
Knowledge of FDA regulated biotechnology or drug validation requirements including knowledge of FDA 21 CFR Parts 210 and 211
Knowledge of Statistical software and calculations
Knowledge of manufacturing processes, sampling techniques, government regulations and guidelines pertaining to those areas
Knowledge of SCADA control system
Strong understanding of cGMPs and validation/qualification concepts
Ability to read, program, troubleshoot PLC Ladder Logic and HMI software
Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process
Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies and protocol generation, and protocol execution
Ability to perform qualification and validation reporting
PC proficiency using Microsoft Office suite
Excellent written and verbal communication skills
Highly organized and detailed
Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, blueprints as well as cGMP and SOPs
Ability to accurately perform mathematical calculations required by work assignments
Bachelor's degree in Chemistry, Pharmacy, Engineering or related Science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry
Three years proven experience in validation, with particular knowledge of 21 CFR Part 210 and 211
Experience in 21 CFR Part 11 desired
Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefitsgroup@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
