Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job DescriptionAt our Greenville, North Carolina site, you'll join a highly collaborative Validation Engineering team supporting pharmaceutical manufacturing operations. Our team plays a critical role in ensuring manufacturing processes are validated, compliant, and capable of consistently producing high-quality medicines that improve lives around the world.
Discover Impactful WorkAs a Validation Engineer III, you will support manufacturing process validation activities focused primarily on Oral Solid Dose (OSD) continuous manufacturing and pharmaceutical packaging operations. You'll lead validation efforts from protocol development through execution and final reporting while partnering with Manufacturing, Engineering, Quality, and Technical Operations teams.
This role offers an excellent balance of technical documentation and hands-on manufacturing support, allowing you to contribute directly to product launches, process improvements, and regulatory compliance. In addition to OSD process and packaging validation, you'll have opportunities to support Automated Visual Inspection (AVI) validation activities as business needs require.
A Day in the LifeThis position offers approximately:
- 70% desk-based work
- Write validation protocols and supporting documentation
- Perform data analysis and calculations
- Prepare validation summary reports
- Conduct data review and documentation review
- Support investigation and technical problem solving
- 30% manufacturing floor execution
- Execute manufacturing process validation protocols
- Perform packaging process validation activities
- Collect validation samples and process data
- Partner with Manufacturing and Quality during validation campaigns
- Support Automated Visual Inspection (AVI) validation activities when needed
Key Responsibilities- Lead manufacturing process validation activities for Oral Solid Dose (OSD) pharmaceutical products.
- Develop, execute, and document validation protocols, including IQ, OQ, and PQ.
- Perform packaging process validation for commercial pharmaceutical manufacturing.
- Analyze validation data and prepare technical reports that support regulatory compliance.
- Support cleaning validation activities as part of overall manufacturing process qualification.
- Collaborate with Manufacturing, Engineering, Quality, and Technical Operations teams to execute validation projects.
- Participate in peer review of validation documentation and data.
- Support Automated Visual Inspection (AVI) validation activities as assigned.
- Contribute to continuous improvement initiatives that enhance manufacturing performance and compliance.
- Support internal audits, customer audits, and regulatory inspections.
Keys to SuccessEducation- Bachelor's degree in Engineering, Life Sciences, Chemistry, or another technical discipline.
- Advanced degree preferred.
Experience- Bachelor's degree with 5+ years of validation experience, or an advanced degree with 3+ years of validation experience within pharmaceutical, biotechnology, or another regulated manufacturing environment.
- Experience developing and executing validation protocols in GMP manufacturing.
- Experience with IQ/OQ/PQ documentation and execution.
Preferred ExperienceCandidates with the following experience will be especially successful in this role:
- Oral Solid Dose (OSD) manufacturing process validation
- Continuous Manufacturing (CM)
- Packaging process validation (preferred over equipment-only validation)
- Automated Visual Inspection (AVI)
- Sterile packaging validation
- Cross-functional collaboration within pharmaceutical manufacturing
Knowledge, Skills & Abilities- Strong knowledge of FDA cGMP regulations and pharmaceutical manufacturing practices.
- Experience with manufacturing process validation, equipment qualification, utilities, cleaning processes, and computer systems.
- Strong technical writing and documentation skills.
- Experience performing validation data analysis and interpretation.
- Excellent analytical and problem-solving skills.
- Strong communication and collaboration skills with cross-functional teams.
- Proficiency with Microsoft Office and validation documentation systems.
- Experience supporting regulatory inspections and customer audits is preferred.
- Knowledge of Lean Manufacturing or continuous improvement methodologies is a plus.
- Ability to work in cleanroom and manufacturing environments.
- Flexibility to occasionally support extended hours during validation campaigns.
- Occasional travel (up to 25%) may be required to support Factory Acceptance Testing (FAT) or other business needs.
