Validation Consultant

Summary:

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 Analytical Balance, LOD Instrument, Micrometer, Friabilator, Hardness Tester, Calculator, Particle Size Analyzer, Disintegration Apparatus, Viscometer

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

Language Required: English

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 . We will make a determination on your request for reasonable accommodation on a case-by-case basis.