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.

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.

Key Responsibilities

• Lead and support technical transfer and process validation activities for pharmaceutical manufacturing processes.
• Design and manage studies supporting process development, optimization, scale-up, characterization, and technology transfer.
• Develop and execute protocols for engineering runs, process validation, and Process Performance Qualification (PPQ) activities.
• Analyze manufacturing and process data to evaluate critical process parameters and overall process performance.
• Serve as a technical SME for manufacturing processes and transfer of new products into production.
• Support sterile fill/finish and drug product manufacturing operations.
• Investigate manufacturing issues including deviations, OOS/OOT events, root cause investigations, and process-related quality events.
• Author and review technical documentation including:
• Validation protocols and reports
• Engineering study protocols
• Deviations and investigations
• Risk assessments
• Gap analyses
• SOPs and technical reports
• Apply Quality by Design (QbD) principles to process development and characterization activities.
• Collaborate cross-functionally with Manufacturing, Quality, Analytical, Engineering, and Project Management teams.
• Review commercial manufacturing data to support process performance and batch disposition activities.
• Manage multiple technical projects and communicate complex technical information to stakeholders and leadership.
• Ensure all activities are performed in accordance with cGMP and good documentation practices.

Qualifications

• Bachelor's degree in Engineering, Science, Pharmaceutical Sciences, or a related technical discipline.
• Minimum of 7 years of relevant pharmaceutical or biopharmaceutical manufacturing experience.
• Strong experience with process validation and PPQ.
• Experience supporting sterile fill/finish or aseptic drug product manufacturing.
• Experience with technology transfer / technical transfer of manufacturing processes.
• Knowledge of process development, scale-up, process optimization, and process characterization.
• Strong understanding of cGMP requirements and pharmaceutical manufacturing practices.
• Demonstrated ability to analyze complex process and manufacturing data.
• Strong technical writing skills with experience authoring protocols, reports, investigations, and other GMP documentation.
• Ability to manage multiple priorities and work effectively in a fast-paced manufacturing environment.
• Strong communication, problem-solving, and cross-functional collaboration skills.

Preferred Experience

• Experience with QbD, critical process parameters (CPPs), and process robustness studies.
• Experience supporting regulatory submissions or regulatory-facing manufacturing activities.
• Experience with deviation investigations, root cause analysis, OOS/OOT investigations, and CAPA-related activities.
• Previous experience serving as a technical lead or SME within an MS&T, Process Engineering, Technical Operations, or Manufacturing organization.