Process Engineer
Durham, NC
Full Time
Experienced
Bonus Potential | Matched Pension Contributions/401k | Annual Leave/PTO | Employee Assistance Program
Core Values: Diligence, Pioneering, Integrity, Dignity
Job Title: (Senior) Process Engineer
Location: Durham, NC
Reports to: Head of Manufacturing
On-site Expectations:
- 100% on-site position.
MedPharm is a global leader in topical and transdermal product development, providing end-to-end services from early-stage formulation development to full commercial production. With facilities in the UK and the US, MedPharm has established itself as a trusted partner in dermatological, nail, mucosal, respiratory, and transdermal drug delivery. MedPharm has a strong track record of supporting product development and pioneering performance testing models to reduce development risks for its clients.
Job Summary:
Medpharm seeks a talented 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.
Essential Duties and Responsibilities
- 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.
- 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
Our breadth of competencies has us partnering with clients from formula inception, clinical trials, regulatory filing and into commercial production. We are engaged in all stages of the pharmaceutical commercialization process, and you will work with some of the best clients in our industry’s CDMO space.
Diversity and Inclusion:
MedPharm is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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