Cleaning Validation Engineers (100% onsite, Raleigh/Durham, NC)

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
No Travel Required
Able to Provide Sponsorship

Skills

Cleaning-In-Place (CIP)
cleaning validation execution
MACO

Job Details

100% onsite, no remote no hybrid

Raleigh/Durham (Holly Springs) NC

JOB DESCRIPTION:

Most Important: The candidate needs to have current industry Cleaning Validation knowledge. Past work in CDMO and/or drug product facility is a plus. Kneat 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.

Candidates submitted need to have the below skills and experience that are beside the

  • check marks to have best chance to get hired:
  • Cleaning validation
  • CQV
  • CIP / COP
  • Clean Steam utilities experience preferred, not required, a big plus however
  • Kneat
  • Maco (maximum allowable carryover
  • Rinsing, Swabbing (for cleaning validation)
  • Alcoa
  • Fill finish experience, vial filling
  • Bioreactors, autoclaves, parts, washers , QC lab equipment should be able to validate and qualify this equipment
  • Biologics experience
  • Understand analytical method / analytical method validation
  • 4-8 years total experience

Job Summary:

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 bio-reactors. 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.

Key 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.

Qualifications:

  • 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 bio-reactors, 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 work day and night shifts as operational needs evolve.

Preferred Qualifications:

  • Experience in a large-scale biopharmaceutical manufacturing environment.
  • MACO- MUST
  • KNEAT experience a plus, CQV experience is very helpful
  • 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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.