The Opportunity:In this exciting role, you will be an integral member of the User Team and will provide scientific and technical impact for the new large-volume manufacturing facility in Holly Springs. This role specifically focuses on the design, qualification, start-up, and registration of the facility's Dispensing, Compounding, and Powder Handling area.
As a key member of our technical team, this role will participate and focus on process safety and high-containment engineering to manage the hazards posed by a low-OEL material with highly sensitive flammability and electrostatic characteristics. Following the go-live of the facility, you will transition into a routine position at the site, extending into daily operational responsibilities.
As a member of the engineering team, you will be accountable for:
- Technical acumen: You will provide project management, technical design, testing, qualification, and validation for all activities related to the dispensing and compounding area.
- Safety & Hazard Mitigation: You will support and implement the engineering control strategy required to safely manage flammability and hybrid material risks and electrostatic hazards of the API.
- Cross-Functional Collaboration: You will partner with Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, and CMO organizations to drive technical decisions that balance project, product, quality, and operations views.
- Process Design & Scalability:You will design geometrically similar compounding trains (150L and 750L) to ensure scalable mixing dynamics across a wide range of batch sizes (50L to 700L), including buffer preparation and pH-controlled compounding.
- Project Execution: You will participate in assigned parts of the project, justifying goals to management, and working with suppliers/contractors to transition design plans into a functioning, approved manufacturing process.
- Regulatory Submission:You will support the design and execute studies and comparability protocols to support operations and contribute directly to cGMP documentation and regulatory filings.
Who you are:- You hold a Bachelor's, Master's, or Ph.D. degree in Bio/Chemical Engineering or a related discipline, with 2-4 years of experience in the pharmaceutical industry
- You are familiar with aseptic compounding, fluid dynamics, automated powder handling.
- Influencer: You understand the "bigger picture" of large-volume, low-cost manufacturing and can effectively partner with and influence stakeholders across the organization without formal authority.
- Champion of Safety: You foster a positive safety culture where no one gets hurt, ensuring environmental health, safety, and security are integrated into all business and manufacturing processes.
Preferred:
- You have experience with "Smart Factory" concepts and digital transformation to drive business and project efficiency.
- You have direct experience defending process design and safety concepts during Health Authority inspections.
- You have advanced knowledge of global ATEX/NEC standards for hybrid mixture environments.
Work Environment/Safety Considerations:
- Ability to work in an international/global environment. Domestic and international travel required. Travel up to 20% after full relocation.
- Will work in a clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.
- Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.
This role will require full onsite work at the project office before transition to the site offices once complete.
The expected salary range for this position in Holly Springs, NC is $78,000 - $146,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are provided.
Link to Benefits
