Senior Cleaning Validation Engineer (GMP | CIP | Risk-Based)

ProQuality Network; Indianapolis (IN); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

ProQuality Network is seeking a Cleaning Validation Engineer/Specialist to develop, execute, and maintain cleaning validation programs for pharmaceutical manufacturing. You will ensure removal of residues, cleaning agents, and contaminants to established criteria and collaborate with Analytical and Microbiology teams to meet GMP expectations.

The role involves designing strategies, risk assessments, sampling plans, and validation reports, while supporting regulatory inspections and continuous

Formación

• Bachelor’s degree in a relevant scientific/technical discipline.
• 3+ years in cleaning validation, process validation, or GMP manufacturing.
• Hands-on experience developing and executing cleaning validation protocols.
• Strong GMP knowledge and cleaning validation concepts.
• Experience with swab and rinse sampling techniques and strategies.
• Experience with risk assessments and worst-case product/equipment selection.
• Experience investigating deviations and failures in cleaning validation.
• Strong technical writing and documentation skills.
• Ability to work with Quality, Manufacturing, Engineering, Analytical, and Microbiology teams.

Responsabilidades

• Develop and execute cleaning validation strategies, protocols, and reports for equipment and surfaces.
• Maintain Cleaning Validation Master Plans, risk assessments, SOPs, sampling plans, and reports.
• Identify worst-case products and equipment for cleaning validation based on multiple factors.
• Establish acceptance criteria for residues, cleaning agents, and microbiological contamination.
• Develop sampling plans and validate swab and rinse strategies.
• Coordinate sampling activities and ensure proper handling of samples.
• Work with Analytical and Microbiology teams to define analysis requirements.
• Evaluate results and determine if processes meet acceptance criteria.
• Support MACO calculations, residue limits, and CIP systems reviews.
• Assist root cause investigations, CAPA, and change control related to cleaning validation.
• Support periodic review and regulatory inspections with documentation.

Conocimientos

Analytical ability

Problem solving

Technical writing

Cross-functional collaboration

GMP principles

Educación

Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, Microbiology, or related

Descripción del empleo

ProQuality Network is seeking a Cleaning Validation Engineer/Specialist to develop, execute, and maintain cleaning validation programs for pharmaceutical manufacturing. You will ensure removal of residues, cleaning agents, and contaminants to established criteria and collaborate with Analytical and Microbiology teams to meet GMP expectations.

The role involves designing strategies, risk assessments, sampling plans, and validation reports, while supporting regulatory inspections and continuous