Talnt · 16 hours ago
Validation Engineer
Minneapolis, Minnesota, United States
Full-time
Onsite
Mid Level
3+ years expTalnt is seeking a Validation Engineering Specialist responsible for executing qualification and validation activities for OTC pharmaceutical and personal care products. This role ensures compliance with cGMP, FDA, and OTC regulatory requirements while collaborating cross-functionally to support new product introductions and ongoing compliance initiatives.
Staffing & Recruiting
Responsibilities
Execute facility, utility, and equipment qualification activities, including IQ, OQ, and PQ protocols
Support process validation and process performance qualification activities for OTC and personal care manufacturing processes
Assist with the development, execution, and documentation of cleaning validation studies
Conduct computer system validation activities in alignment with regulatory and data integrity requirements
Support the development, review, and maintenance of validation documentation, including SOPs, protocols, reports, and batch records
Collaborate with Quality Assurance, Process Engineering, Production, and subject matter experts to develop and execute pFMEAs and risk assessments
Participate in process trials, validation runs, and pilot batches to establish robust and reliable manufacturing processes for new formulations
Manage assigned validation projects to ensure timely completion and alignment with project milestones
Prepare and present validation reports, technical summaries, metrics, and project updates to senior leadership
Support audit readiness by participating in internal and external audits, addressing observations, and implementing corrective and preventive actions
Qualification
Required
Bachelors degree in chemistry, physical sciences, engineering, or a related scientific discipline
Minimum of three years of experience in pharmaceutical and or personal care validation, including experience in Rx or OTC manufacturing environments
Strong knowledge of cGMP regulations, FDA requirements, and OTC compliance standards
Demonstrated experience with facility, utility, and equipment qualification requirements
Working knowledge of process validation, process performance qualification, and cleaning validation principles
Experience performing computer system validation in regulated manufacturing environments
Proven ability to develop, execute, and maintain compliant validation systems and documentation
Strong technical writing, record keeping, and data analysis skills
Excellent communication skills with the ability to collaborate effectively across functional teams and organizational levels
Preferred
Lean Six Sigma certification, Green Belt or higher
Experience supporting new product introductions and scale up activities in OTC or personal care manufacturing
Familiarity with risk management tools and methodologies used in regulated environments
Demonstrated leadership ability in managing validation projects and cross functional initiatives
Company
Talnt
Talnt uses AI and automation to identify and qualify candidates quickly.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Emmet Nitto
Founder
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