Cleaning Validation Engineer

Overview

Tri-Pac, Inc. is a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers.

Location:

South Bend, Indiana, United States (On-site).

• Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP/SIP qualification), cleaning validation, computer system validation and process validation. Scope includes drafting qualification protocols and summary reports, field execution, and data analysis.
• Coordinate and provide directions to contract personnel performing validation activities as needed.
• Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other life cycle documents to support validation efforts.
• Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, and technical assessment reports.
• Support cleaning and sterilization development activities (including CIP/SIP, manual cleaning, steam sterilization).
• Support periodic requalification and revalidation efforts.
• Work independently and interact with personnel from multiple departments including Technical Development, Manufacturing, Engineering, MAC, QC, and QA.
• Support gap assessment/closure, corrective actions, and compliance remediation related to Validation.
• Represent Validation as SME during regulatory or customer inspections as needed.
• Mentor and manage full-time validation engineers/specialists and contractors as assigned.

• Minimum Bachelor's Degree in Engineering or Science discipline; advanced degree is a plus.
• Minimum 5+ years of relevant validation experience in a regulated industry. Proficient in at least 3 of 7 validation core expertise.
• Expertise in Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation.
• Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g., 21 CFR ,, 820).
• Familiar with current industry guidance documents (e.g., FDA Process Validation guidance, ISO 13485, PDA Technical Reports).
• Experience with customer and regulatory inspections.
• Strong understanding of quality risk management principles, including risk-based C&Q approaches.
• Hands-on validation experience in developing validation documentation and field execution.
• Project management experience is a plus.
• Aerosol production experience is a plus.

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training.

Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

Thank you for your interest and consideration of a career with Tri-Pac, Inc.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer.