Cleaning Validation Engineers

Katalyst Healthcares & Life Sciences; Durham (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading healthcare firm is hiring a Cleaning Validation Worker with significant experience in biopharmaceutical manufacturing. The role includes developing, executing, and optimizing cleaning validation protocols and ensuring compliance with regulatory standards in a dynamic environment. Ideal candidates will possess strong problem-solving skills and technical expertise in cleaning validation processes.

Qualifications

• 5+ years of experience in cleaning validation focused on CIP processes.
• Familiarity with regulatory standards like 21 CFR Part 11 and ICH Q7.
• Experience with large-scale biopharmaceutical manufacturing equipment.

Responsibilities

• Lead cleaning validation activities for biopharmaceutical production.
• Ensure compliance with cleaning validation protocols and regulatory requirements.
• Provide training and support for cleaning validation processes.

Skills

Cleaning Validation

Problem-Solving

Technical Writing

Flexibility

Education

Bachelor's degree in Chemical Engineering, Biotechnology, or Chemistry

Tools

Knead

Job description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description:

• Here are the details of what candidates need experience with – these are the keys below to getting the interview and getting hired – they are wanting people that fit this exact Mold below as best as possible – anyone outside of the Mold will be an uphill battle to get an interview.
• The candidate needs to have current industry Cleaning Validation knowledge. Past work in CDMO and/or drug product facility is a plus. Knead experience is really needed. The candidate needs to be able to work across functions and departments. Strong Biologics experience preferred - DPFG (Drug Product Finish Goods Team) vial fill finish most important must have experience. Looking for strong references to be considered and hired.
• Shift: Primarily Day Shift; potential for Night Shift work in the future.
• We are seeking an experienced Cleaning Validation Workers to work on and execute cleaning validation activities in a dynamic biopharmaceutical environment. This role focuses on Cleaning-In-Place (CIP) processes, cleaning validation execution, and large equipment cleaning strategies, including bioreactors.
• The ideal candidate will bring expertise in cleaning validation, MACO (Maximum Allowable Carryover) assessments, and method validation, ensuring compliance with regulatory requirements and company standards.

Responsibilities:

• Lead cleaning validation activities, including CIP cycle development, execution, and optimization for large equipment (e.g., bioreactors, tanks, and ancillary systems).
• Conduct cleaning validation studies, execute protocols (IOQ/PQ), and ensure thorough documentation in compliance with regulatory requirements (e.g., FDA, EMA).
• Perform MACO calculations and assessments to determine acceptable residue limits for equipment cleaning.
• Collaborate with cross-functional teams to design and execute cleaning validation strategies and methodologies.
• Develop and execute cleaning validation protocols and reports, ensuring compliance with cGMPs and ALCOA+ principles.
• Provide subject matter expertise in cleaning validation execution and troubleshooting for cleaning processes.
• Lead method validation efforts related to cleaning validation (e.g., swab and rinse sampling).
• Ensure alignment with process and equipment design specifications for cleaning requirements.
• Provide technical training and guidance to operators and validation personnel on cleaning validation principles and techniques.
• Support audits and inspections by providing cleaning validation documentation and expertise.
• May participate in shift work as required to support cleaning validation activities during different phases of production.

Requirements:

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., Chemical Engineering, Biotechnology, Chemistry) or equivalent experience.
• 5+ years of experience in cleaning validation, with a strong focus on CIP processes and large equipment.
• Proven expertise in MACO calculations, cleaning validation protocol execution, and method validation techniques.
• Familiarity with biopharmaceutical manufacturing processes and regulatory standards (21 CFR Part 11, ICH Q7, etc.).
• Hands-on experience with large-scale equipment, including bioreactors, tanks, and associated cleaning systems.
• Strong problem-solving skills and ability to troubleshoot cleaning-related issues effectively.
• Excellent technical writing and documentation skills.
• Flexibility to workday and night shifts as operational needs evolve.
• Experience in a large-scale biopharmaceutical manufacturing environment.
• MACO- MUST.
• Knowledge of automated cleaning systems and CIP equipment design.
• Familiarity with process validation and cross-contamination control strategies.
• Small Parts COP and CIP execution experience.
• 4-8 years of experience (if close to this is okay).
• must be able to walk them through in detail the entire cleaning validation process starts to finish in an interview.
• CQV.
• ALCOA.
• MACO.
• Knead (paperless validation software).
• Works with fill finish process or filling machines.
• Worked with bioreactors, autoclaves, parts, washers.
• Mapping, temperature mapping.
• Familiar with analytical method.

Additional Information

All your information will be kept confidential according to EEO guidelines.