What are the responsibilities and job description for the Senior Process Engineer position at Stanley Cowton International?
Process Engineer – Active Pharmaceutical Ingredients (API)
Location: Hopewell, VA
About the Opportunity:
A rapidly growing pharmaceutical manufacturer in Hopewell, VA is on a mission to reshape the pharmaceutical landscape in the U.S. With an expanding portfolio, this is an exciting time to join a company committed to domestic API (Active Pharmaceutical Ingredient) production. This role offers an unparalleled chance to contribute to the future of pharmaceutical manufacturing while advancing your career in a fast-paced, dynamic environment.
Why Join Us?
- Impactful Work: Be part of a transformative initiative ensuring the U.S. has secure access to essential medicines.
- Career Growth: With plans for nationwide expansion, the opportunities for professional development are unmatched.
- Innovative Environment: Thrive in a start-up atmosphere that values adaptability, creativity, and hands-on problem-solving.
Position Overview:
We are seeking a highly skilled Process Engineer with strong API (Active Pharmaceutical Ingredients) experience. This role will focus on scaling processes from bench to kilo and kilo to metric ton production. The ideal candidates will have expertise in tech transfer, process scale-up, and batch record documentation, while navigating the challenges and excitement of a growing organization.
Key Responsibilities:
- Lead the transfer of technology from R&D to full-scale production, ensuring seamless integration and scalability.
- Develop and write clear, concise batch records and work instructions with direct input from operators.
- Oversee process scale-up from bench-scale (20L) to kilo-scale (100L) and up to metric ton-scale (2000 gallons).
- Conduct root cause analysis (RCA) and implement corrective actions, contributing to continuous improvement.
- Collaborate with R&D scientists, operators, and supervisors to optimize processes and troubleshoot issues.
- Provide mentorship and coaching to operators and junior engineers.
- Conduct thorough process safety analysis and participate in Process Hazard Analysis (PHA).
- Recommend and evaluate equipment for various processes, focusing on both small-scale and large-scale operations.
Required Skills and Qualifications:
- API industry experience is essential.
- Proven expertise in tech transfer from R&D to production.
- Strong background in writing GMP-compliant batch records and documentation.
- Demonstrated ability in root cause analysis (RCA) and implementing CAPA.
- Hands-on experience with kilo facilities and metric ton production, including handling potent compounds.
- Excellent communication skills to engage with operators, supervisors, and R&D teams.
- Strong mechanical aptitude and equipment knowledge for process troubleshooting and recommendations.
- Ability to excel in a fast-paced, start-up environment, demonstrating grit, ambition, and self-starter qualities.
- Bachelor’s degree in Chemical Engineering or equivalent required
- Experience in a cGMP environment and familiarity with FDA regulations
Career Path and Growth:
Whether you prefer to remain technical or aspire to leadership, this role offers numerous pathways. The right candidate could advance to Process Engineering Manager and beyond, contributing to the company’s broader expansion plans.
Interview Process:
- Initial Virtual Interview with the hiring team.
- Follow-up discussions with key stakeholders.
- Onsite Visit to meet the team and tour the facilities.
Ready to Make a Difference?
If you’re passionate about contributing to a mission-driven company with vast growth potential, this is the opportunity for you. Apply now to be part of a team that’s redefining pharmaceutical manufacturing in the U.S.
