BioSpace is hiring: Engineer II – Cleaning Validation in Petersburg

Overview

Engineer II – Cleaning Validation role at BioSpace.

We are looking for an Engineer who will be responsible for leading the cleaning validation program to support new and modified equipment, products, and processes, in support of project, operational, and quality objectives to ensure they are run in accordance with GMP regulation and site procedures.

Responsibilities

• Lead the development and execution of cleaning validation design, qualification, and validation protocols for various equipment and systems.
• Responsible for all phases (stages 1, 2 and 3) of the cleaning validation activity, including requirements gathering, validation planning, protocol generation, test execution, design documentation, and system release.
• Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
• Evaluate System Change Controls for Validation Impact. Support Change Qualification through the creation of relevant Change Actions.
• Support the development of Standard Operating Procedures for new processes and equipment.
• Serve as Principal Investigator for cleaning validation-related excursions.
• Contribute to the continuous improvement of validation processes and procedures.
• Support other areas of validation, as needed, including equipment, sterilization, utilities, and facilities.

Basic Qualifications And Capabilities

• Bachelor’s degree in engineering or relevant sciences and 6+ years of validation experience, with specialization in cleaning validation.
• Knowledge and experience with all phases/stages (1, 2 and 3) of cleaning validation, including maximum carryover calculations for limits assessment, understanding and application of Health Based Exposure Limits (HBEL), ADE/PDE, NOEL, VRL, cycle development, rinse and swab method analytical and recovery studies, sample collection, worst case assessment for equipment and products, spray ball coverage testing, continued cleaning process verification after equipment release.
• Experience with cleaning validation of Formulation/Filling vessels, Filling equipment (example: manifolds/needles, etc.), CIP skids and Parts Washer.
• 6+ years’ experience with sterile injectables, combo-devices, or biologics.
• Experience with personnel training for visual inspection and swab qualification.
• Advanced degrees or certifications relevant to the role is a plus.
• Knowledge of regulatory requirements (cGMP, FDA, WHO, etc.).
• Experience authoring, approving, and executing cleaning validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
• Experience in a process improvement environment, including change management and participating in Lean/Six Sigma project teams.

Preferred Qualifications

• Experience with single-use components in drug product formulation, process validation, sterile filtration, and aseptic filling applications.
• Start-up experience preferred

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

• Quality Assurance

Industries

• Internet News

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