Oxford Global Resources

Validation Consultant

Oxford Global Resources • $131K — $172K *
Marietta, PA 17547In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Chemistry, Pharmacy, Engineering, or related Science, or equivalent experience.
  • Three years of proven experience in validation, specifically with knowledge of FDA 21 CFR Parts 210 and 211.
  • Strong understanding of cGMP regulations and validation/qualification concepts.
  • Proficient in statistical software and calculations.
  • Familiarity with FDA regulated biotechnology or drug validation requirements.

Responsibilities

  • Prepare and execute cleaning, process, and packaging validation plans.
  • Develop and execute equipment qualification protocols for processing and packaging.
  • Perform in-process sampling and physical testing as per validation protocols.
  • Analyze validation study data using statistical methods to determine process capabilities.
  • Write summary reports for validation activities and maintain orderly documentation.

Benefits

  • Opportunity to work in a compliance-driven environment within the pharmaceutical industry.
  • Engagement with cross-functional teams, enhancing teamwork and process improvement skills.
  • Exposure to cutting-edge equipment and technologies in the biotechnology sector.
Full Job Description
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

Hourly Rate: 63-83

About Oxford Global Resources

Oxford Global Resources is a staffing and recruiting company that provides temporary and permanent staffing solutions to clients in a variety of industries. The company was founded in 1984 and is headquartered in Cambridge, Massachusetts. Oxford Global Resources offers a range of services, including contract staffing, direct hire, and temp-to-perm staffing. The company's clients include some of the world's leading companies in the biotechnology, pharmaceutical, and medical device industries, as well as government agencies and other organizations. Oxford Global Resources is committed to providing high-quality staffing solutions that meet the unique needs of each client.
Learn more about Oxford Global Resources
Size
500 employees
Industry
Staffing
Founded
1984
* Ladders Estimates

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