Aseptic Process Development Engineer (6-month contract)

We are seeking an experienced Process Engineer – Technical Transfer for a 6+ month contract to support pharmaceutical manufacturing, process validation, and technology transfer activities within a Manufacturing Science & Technology (MS&T) environment.

JOB SUMMARY

Responsible for optimizing aseptic filling operations and auxiliary processes by overseeing the process data gathering, implementing equipment design changes, installing new equipment, and troubleshooting process upsets in processes, equipment, and systems. Serve as the technical liaison between production, project engineering, maintenance, MS&T, and quality during projects, quality investigations, and corrective actions implementation.  Design, lead, and execute sound engineering studies and implement controls and procedures aimed at reducing downtime, reducing process waste, increasing yield, and complying with all regulatory standards.

This position will support multiple technical transfer and process validation projects, with a strong focus on sterile fill/finish operations, drug product manufacturing, process development, scale-up, and process optimization.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Develop, implement, and improve aseptic filling and auxiliary processes.
• Analyze process performance data and lead continuous improvement initiatives (e.g., OEE, yield, cycle time, waste reduction).
• Lead the develop and improvement of process KPI 
• Support design, specification, procurement, and installation of new equipment or process upgrades.
• Lead or assist in scale-up and tech transfer of sterile products from R&D or external partners
• Develop engineering drawings such as layouts, P&IDs and PFDs
• Lead cross-functional teams on equipment installation, process improvement, and cost-saving projects.
• Develop project plans, timelines, budgets, and resource needs for engineering initiatives.
• Provide technical support in deviation investigations, CAPAs, and change controls
• Analyze process data to support investigations and identify process improvements.
• Lead process risk assessments by applying standard project risk techniques and developing risk response plans with the project team and stakeholders
• Lead procurement and vendor/contractor selection, constructability reviews, approval of submittals, field execution, commissioning protocol development, and execution
• Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• A minimum of 5 years of experience in a pharmaceutical or related environment.
• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering or equivalent.
• Strong understanding of aseptic techniques and clean room operations.
• Hands-on experience with autoclaves, isolators, RABS, lyophilizers, vial/syringe filling lines, and secondary packaging equipment is preferred.
• Ability to think and act both strategically and tactically
• Highly effective verbal and written communicator at all levels of the organization
• Demonstrated ability to effectively prioritize and coordinate activities
• Proficiency in Microsoft Office applications
• OTJ experience with process design requirements for a pharmaceutical, biotech, or food industry (ISPE Baseline Guides, ISO and ASME BPE, EU/FDA Regulations for biological and drug products)
• Experience with regulatory inspections and validation activities.
• Strong analytical and problem-solving skills.
• Proficient in data analysis tools and process monitoring systems.
• Knowledge of Six Sigma, Lean, or other continuous improvement methodologies. Certification is preferred.
• Excellent written and verbal communication skills.
• Ability to work in a fast-paced, regulated environment and manage multiple priorities.