What are the responsibilities and job description for the Process Subject Matter Expert - Spray Drying position at Blackfield Associates?
Looking to the next step in your Process engineering career?
We are hiring for a leading global biopharmaceutical manufacturing company to expand their ever-growing team by hiring a Process Subject Matter Expert in Indiana.
Key Responsibilities:
- Act as the process SME for spray drying within a major CAPEX program, supporting design, build, and startup of new manufacturing capabilities
- Provide technical leadership across project lifecycle stages including concept design, FEED, detailed design, commissioning, and qualification
- Support vendor selection, technical bid evaluations, and equipment procurement for spray drying and associated unit operations
- Lead process scale-up and technology transfer into the new facility, ensuring alignment with commercial manufacturing requirements
- Oversee and support commissioning, qualification (CQV), and startup activities, ensuring systems perform as intended
- Drive process troubleshooting and risk mitigation during project execution and early manufacturing phases
- Partner with engineering, project management, and operations teams to ensure on-time, on-budget project delivery
- Ensure compliance with GMP, safety, and regulatory standards throughout the project lifecycle
- Provide ongoing SME support post-startup to stabilize and optimize spray drying operations
Requirements:
- Extensive experience in pharmaceutical or chemical manufacturing, with strong expertise in spray drying technologies (API focus preferred)
- Proven track record supporting CAPEX projects (e.g. facility builds, line expansions, or major equipment installations)
- Deep understanding of end-to-end project lifecycle (FEED, design, build, CQV, startup)
- Experience working with equipment vendors and EPC/EPCM partners
- Strong background in process scale-up, tech transfer, and commercialization
- Demonstrated ability to support commissioning, qualification, and startup of spray drying systems
- Solid knowledge of GMP and regulatory expectations within API manufacturing
- Ability to operate as a senior technical authority, influencing project and engineering decisions
- Degree in Chemical Engineering, Pharmaceutical Engineering, or related discipline.