Process Engineer

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.

Assists with the preparation and maintenance of User Requirements Specifications.

Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations.

Conducting risk assessments and supporting equipment / utilities qualification activities.

Hands-on experience with troubleshooting and resolving process equipment-related issues during production.

Experience managing equipment, Preventive Maintenance, Calibration, and reliability programs independently with minimum supervision.

Experience with OSD equipment but not limited to Wet Granulation systems, Bin Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller Compactors, etc. is a must.

Experience in packaging equipment like bottle packaging, blister packaging, and powder packaging.

Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs.

Experience in writing Change Controls, Investigation reports, Work Orders, CAPA, Standard Operating Procedures (SOP), and risk assessments.

Analyzing process data and driving continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality.

Providing technical support and training to production staff on new processes, equipment, and safety protocols.

Identifies and proposes process improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution.

Performs other related duties as assigned.

3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products 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.

Proficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc.

Preferred Qualifications :

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 / packaging equipment for the pharmaceutical industry.

Familiarity with Maximo or equivalent Regulatory Asset Manager software.

Experience / Education :

Bachelor's degree in engineering (Mechanical, Electrical, Industrial) or a related field.

5+ years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment.

Knowledge / Skills / Abilities :

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

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.