Berkshire Sterile Manufacturing is hiring a Senior Process Engineer to lead the design, development, and optimization of manufacturing processes for parenteral drug products. This is a hands-on, technical leadership role focused on formulation development, process scale-up, and manufacturing troubleshooting, with a constant emphasis on safety, quality, and operational performance.

What You'll Do

Analyze pharmaceutical excipients for chemical and physical compatibility with active drug molecules.
Propose and develop lyophilization or other complex formulation processes.
Lead scale-up and technology transfer activities from R&D to manufacturing.
Identify and procure required materials, tooling, and equipment for development and manufacturing.
Create master batch records, study protocols, SOPs, and other operational or quality documents.
Conduct due diligence on manufacturing process design and perform risk analysis.
Propose testing procedures for Critical Quality Attributes and coordinate with Quality Control.
Compile and analyze test data to determine process efficiency or diagnose malfunctions.
Analyze in-process and release testing results to design and control manufacturing processes.
Maintain ownership of assigned laboratory instruments.
Study the effects of manufacturing techniques and packaging on product stability.
Develop or improve equipment, formulas, processes, or analytical methods.
Write technical reports and prepare standards and specifications.
Develop equipment and processes that meet all safety codes, policies, and guidelines.
Lead or support validation activities, including equipment and process validation.
Lead problem-solving and investigations for quality events related to formulation or batch records.
Propose and lead process improvement initiatives for operational performance and lab safety.
Lead or participate in root cause analysis for OOS results and deviations.
Supervise, mentor, and develop team members and cross-functional personnel.
Carry out all responsibilities in compliance with FDA, OSHA, EPA, and DEP regulations.

What We're Looking For

Bachelor’s degree or higher in Chemical Engineering, Chemistry, Biology, or Pharmaceutical Science.
A minimum of three (3) years of experience in pharmaceutical research and manufacturing.
Knowledge of parenteral drug product manufacturing.
Proficient with calculation, data analysis, statistics, and applied mathematics.
Exceptional computer skills, including Microsoft Office, Visio, or related software.
Excellent writing skills and strong attention to detail.