Senior Principal Process Engineer & Tech Transfer Leader

Biopharma Careers; City of Mount Vernon (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Biopharma Careers is seeking an Associate Director Principal Engineer to provide expert technical support for formulation and manufacturing processes. You will lead technology transfers, optimize productivity, and drive continuous improvement across GMP-compliant operations.

The role requires hands-on leadership, collaboration with cross-functional teams, and mentoring of junior engineers. Strong background in solid oral dosage form development and regulatory compliance is essential.

Qualifications

• Bachelor’s degree required in Science, Chemical Engineering, or related field.
• Minimum of 10 years’ experience in pharmaceutical production, process engineering, or project engineering.
• Strong understanding of cGMPs; demonstrated leadership and technical capabilities.
• Experience with product/process development, scale‑up, and continuous improvement.
• Excellent verbal, written, and interpersonal communication skills.

Responsibilities

• Provide technical support for formulation and manufacturing; investigate and correct process deviations.
• Lead and manage technology transfers to and from the site.
• Collaborate with Production, Engineering, Automation, and Quality to optimize productivity and supply reliability.
• Design and execute process qualifications, validations, and CTQ assessments.
• Mentor engineers and interns; drive process improvements and cost reductions.
• Lead site-wide PAT strategy and scale-up activities for solid oral dosage forms.

Skills

Leadership

Project management

Communication (verbal)

Communication (written)

Process troubleshooting

Process development

Education

Bachelor’s degree in Science/Engineering

Master’s degree or PhD (desirable)

Tools

IQ/OQ/PQ validation

Statistical Process Control

Job description

Biopharma Careers is seeking an Associate Director Principal Engineer to provide expert technical support for formulation and manufacturing processes. You will lead technology transfers, optimize productivity, and drive continuous improvement across GMP-compliant operations.

The role requires hands-on leadership, collaboration with cross-functional teams, and mentoring of junior engineers. Strong background in solid oral dosage form development and regulatory compliance is essential.