Manager Manufacturing, Single Use Systems & Validation

Role Summary

Manager Manufacturing, Single Use Systems & Validation

Responsibilities

• Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area.
• Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation.
• Lead development and execution of the site’s Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning validation strategies.
• Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development.
• Coordinate troubleshooting and support during commissioning, qualification, start-up, and process performance qualification of the facility.
• Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions.
• Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections.
• Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies.
• Develop and implement training plans and programs to ensure staff are prepared and compliant.
• Maintain inspection readiness and support staff with audit or regulatory response strategy.

Qualifications

• Basic Qualifications:
  • High school diploma/GED and 12 years of biotechnology operations or validation experience OR
  • Associate’s degree and 10 years of biotechnology operations or validation experience OR
  • Bachelor’s degree and 5 years of biotechnology operations or validation experience OR
  • Master’s degree and 3 years of biotechnology operations or validation experience OR
  • Doctorate degree
• Preferred Qualifications:
  • Educational background in Chemical Engineering, Industrial Engineering, Biology, Biochemistry, Life Sciences, or related field.
  • Experience leading/managing a team of direct reports in a GMP manufacturing environment.
  • Strong technical knowledge of Single Use Systems and Cleaning Validation strategies for biologics manufacturing.
  • Experience in supporting regulatory submissions, audits, and inspections.
  • Proficient technical writing and presentation skills to communicate complex information effectively with technical and senior management staff.
  • Experience in cross-functional project management and operational excellence initiatives.
  • Ability to coach, mentor, and cross-train colleagues within core technical areas.
  • Background in lean manufacturing methodologies and continuous improvement.
  • Knowledge of relevant regulations (e.g., FDA Title 21 CFR Part 210/211, Eudralex Annex 15, ASTM E2500, ICH Q7).

Skills

• Single Use Systems
• Cleaning Validation
• Regulatory compliance and audits
• Technical leadership and mentorship
• Process development collaboration
• Lean manufacturing and continuous improvement
• Technical writing and presentations

Education

• As listed under Qualifications: Bachelor’s degree or higher in a relevant field; advanced degrees preferred.

Additional Requirements

• None beyond listed qualifications and responsibilities.