Hubot | Tri Pac, Inc. CDMO · 1 day ago
Cleaning Validation Engineer
South Bend, IN
Full-time
Onsite
Senior Level
5+ years expTri-Pac, Inc. is a contract development and manufacturing company specializing in liquid and aerosol filling for personal care and pharmaceutical marketers. They are seeking a Cleaning Validation Engineer who will be responsible for the qualification of manufacturing equipment, cleaning validation, and providing direction to contract personnel while ensuring compliance with validation processes.
Medical DeviceConsumer Goods
Responsibilities
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 of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis
As needed coordinate and provide directions to contract personnel performing validation activities
Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort
Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports
Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization) development activities
Support periodic requalification and revalidation effort
Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA
Support gap assessment/closure, corrective actions, and compliance remediation related to Validation
As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections
As assigned mentor and manage fulltime validation engineers/specialist and contractors
Qualification
Required
Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus
Minimum 5+ years of relevant validation experience in regulated industry
Proficient in at least 3 of 7 validation core expertise
Expertise in Facility/Equipment/Utility Qualification
Expertise in Cleaning/Sterilization Cycle Development
Expertise in Cleaning Validation
Expertise in computer system validation
Expertise in Process Validation
Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820)
Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, and applicable PDA Technical Reports)
Experience with customer and regulatory inspection
Strong understanding of quality risk management principles, including best practice in risk-based C&Q approach
Hands on validation experience in developing validation documentation and field execution
Ability to multi-task with a demonstrated track record in meeting deliverable timelines
Ability to think critically and analytically with acumen for troubleshooting and problem solving
Good interpersonal, verbal, and written communication skills
Ability to function effectively and independently in a fast-paced and dynamic environment
Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed
Ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs
Expert with Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills
Understanding of basic statistics, acceptance sampling, and familiarity with statistics software
Preferred
Project Management experience is a plus
Aerosol production experience is a plus
Benefits
Competitive Salary/ Pay & Packages
Vacations
Insurance
401K
Life Insurance
Disability (Long term/ Short term)
Continuous Training
Education Assistance
Company
Hubot | Tri Pac, Inc. CDMO
Hubot CDMO | Tri Pac, Inc.
51-200 employees
H1B Sponsorship
Hubot | Tri Pac, Inc. CDMO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (4)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Dr Pushker Sona
Chief Executive Officer
CA. Shankar V N
Chief Financial Officer
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