Process Engineer

Overview

This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control systems at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed.

• Implementing and maintaining manufacturing process automation and control systems.
• Participate as a member of cross‑functional teams in completion of system impact evaluations and system risk assessments in a multi‑product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced.
• Assist with the preparation and maintenance of User Requirements Specifications.
• Ensure compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations.
• Conduct risk assessments and support equipment/utilities qualification activities.
• Hands‑on experience troubleshooting and resolving process equipment‑related issues during production.
• Manage equipment, preventive maintenance, calibration, and reliability programs independently with minimum supervision.
• Experience with OSD equipment, including but not limited to wet granulation systems, bin blenders, encapsulation, tablet presses, tablet coaters, roller compactors, etc.
• Experience with packaging equipment such as bottle packaging, blister packaging, and powder packaging.
• Collaborate with cross‑functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs.
• Write change controls, investigation reports, work orders, CAPA, Standard Operating Procedures (SOP), and risk assessments.
• Analyze process data and drive continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality.
• Provide technical support and training to production staff on new processes, equipment, and safety protocols.
• Identify and propose process improvement ideas and collaborate with cross‑functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution.
• Perform other related duties as assigned.

• 3‑5 years of experience in a process or equipment engineering role, preferably in the pharmaceutical drug product manufacturing industry.
• Ability to read and understand engineering drawings such as P&IDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications.
• Thorough understanding of cGMP and FDA requirements.
• Strong communication and documentation skills.
• Proven project management skills.
• Experience with equipment qualification following ISPE and ASTM guidelines.
• Proficiency with Microsoft Office Suite, Maximo, calibration program software, MES, etc.

• Prior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing processes and packaging equipment.
• Familiarity with sterile F/F equipment qualification is a plus.
• Familiarity with the IOQ/PQ process with packaging equipment for the pharmaceutical industry.
• Familiarity with Maximo or equivalent regulatory asset manager software.

• Bachelor's degree in engineering (mechanical, electrical, industrial) or a related field.
• 3‑5 years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA‑regulated manufacturing environment.

• Technical:
  Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential.
• Analytical & Problem‑Solving:
  Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions.
• Soft Skills:
  
  Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills. Industry specific: familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA).

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job Location:

US-DE-Middletown