What are the responsibilities and job description for the Validation Engineer position at United Pharma Technologies Inc?
Role: Validation Engineer
Location: Vandalia, OH | Onsite
Position Overview
Our client, a mid-sized pharmaceutical CDMO, is seeking an experienced Validation Engineer to support Oral Solid Dosage (OSD) manufacturing operations within a cGMP-regulated environment.
The Validation Engineer will be responsible for supporting Process Validation, Cleaning Validation, and Commissioning, Qualification & Validation (CQV) activities involving manufacturing equipment, facilities, utilities, and processes. This role will work closely with cross-functional teams to support new product introductions, process improvements, equipment installations, and technology transfers.
Key Responsibilities
- Develop, review, and execute validation documentation, including:
- Validation Master Plans (VMPs)
- IQ/OQ/PQ protocols
- Process Performance Qualification (PPQ) protocols and reports
- Cleaning Validation protocols and reports
- Validation Summary/Final Reports
- Support qualification and validation activities for manufacturing equipment, facilities, utilities, and processes.
- Execute and support Process Validation and Cleaning Validation activities in accordance with approved procedures and regulatory expectations.
- Support residue limit calculations, swab and rinse sampling, and cleaning validation lifecycle strategies.
- Partner with Manufacturing, Quality Assurance, Engineering, MS&T, and Regulatory teams on validation projects.
- Support new product introductions, equipment installations, process improvements, and technology transfers.
- Ensure validation activities comply with FDA, EMA, cGMP, and applicable global regulatory requirements.
- Provide technical troubleshooting and problem-solving support for validation-related issues.
- Maintain accurate and compliant validation documentation and ensure timely completion of assigned activities.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related technical field.
- Strong hands-on experience in pharmaceutical or biopharmaceutical manufacturing.
- Proven experience with OSD (Oral Solid Dosage) manufacturing validation.
- Experience with Process Validation, Cleaning Validation, and CQV.
- Hands-on knowledge of OSD processes such as:
- Blending
- Granulation
- Tablet Compression
- Encapsulation
- Coating
- Packaging
- Experience with cleaning validation programs, including residue limit calculations and swab/rinse sampling.
- Strong understanding of cGMP requirements and FDA/EMA regulatory expectations.
- Excellent technical writing, documentation, communication, and problem-solving skills.
- Ability to work effectively in a fast-paced pharmaceutical manufacturing environment.