GENERAL INFORMATION

Title: Validation/Process Engineer
Date: XXX
Site: Durham, NC
FLSA Status (US Only): Exempt/Non-Exempt
Department: Manufacturing
Reporting To: (Title)

POSITION SUMMARY

Medpharm seeks a talented Validation/Process Engineer for our dynamic Operations Team. This role requires expertise in pharmaceutical technical operations and will support our Manufacturing and Packaging Departments through capital projects and continuous improvement initiatives. Responsibilities include implementing new technologies, ensuring validation readiness, and optimizing processes for operational excellence.

EDUCATION AND EXPERIENCE

• At least 4-6 years of relevant pharmaceutical experience in similar roles, with a strong emphasis on production floor support, technology transfer, and Continuous Improvement initiatives
• Bachelor’s / Master’s Degree in an Engineering discipline
• Strong understanding of GMP regulations and key pharmaceutical unit operations, including their capabilities and associated processes, with a strong preference for experience in liquid and semi-solid dose manufacturing.
• Proficient in the qualification and validation of equipment, facilities, and processes, with the ability to independently prepare qualification documentation with minimal supervision
• Demonstrated ability to independently manage and execute medium- to large-scale projects with minimal supervision.
• Solid understanding of project management principles, including project identification, justification, risk assessment, ROI analysis, cost control, time management, scope definition, and resource allocation.
• Proven experience managing customers, vendors, and contractors independently, with minimal supervision or guidance.
• Demonstrated ability to effectively solve problems and make sound technical decisions within established guidelines, requiring minimal supervision
• Proven leadership skills with the ability to effectively manage teams and achieve goals, even without formal reporting relationships.
• Demonstrated expertise in applying relevant codes and regulations to process and equipment implementation, encompassing OSHA, Fire Code, North Carolina State Building Code / IBC, and MOE standards
• Proficient in written and verbal English communication

KNOWLEDGE, SKILLS, AND ABILITIES

• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.

TRAVEL REQUIREMENTS

• Up to 5%

LIMITATIONS AND DISCLAIMER

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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ESSENTIAL FUNCTIONS

• Provides senior technical expertise and guidance to support the daily operations of the Manufacturing, Packaging, and Maintenance departments, actively troubleshooting issues and driving sustainable improvement initiatives
• Leads critical capital projects, supports new product launches, and represents the Engineering department in both internal and external forums.
• Develops and implements qualification documents in compliance with GMP and MEDPHARM’s Validation Master Plan
• Leads and drives strategic engineering projects by applying effective project management principles, including identification, justification, risk assessment, ROI analysis, and management of cost, time, scope, and resources.
• Develops User Requirement Specifications (URS) for new equipment and actively participates in Factory Acceptance Testing (FAT) and installation processes.
• Contributes to the planning and allocation of capital budgets, Operational Excellence initiatives, and the prioritization of Continuous Improvement projects.
• Develops manufacturing and packaging instructions for new and existing products by adapting customer processes to MEDPHARM’s equipment and operational requirements, utilizing data from line and process test runs. Leverages acquired insights to assist in routing development and optimization.
• Provides senior engineering support and leads troubleshooting efforts on the production floor in collaboration with the Maintenance department.
• Engages in customer process optimization, investigations, equipment selection, and supports customer audits and visits.
• Responsible for the complete operation of MEDPHARM’s Global Track & Trace functions, including customer onboarding and the management of line-level systems and equipment.
• Plans, documents, and executes line trial activities to ensure process efficiency and compliance.
• Other duties as assigned
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.

OTHER DUTIES

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.