Process Engineer

Company & Site Overview

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At the Branchburg, New Jersey, manufacturing facility, our mission is to establish a state-of-the-art pharmaceutical manufacturing plant dedicated to producing high-quality, sterile injectable IV bag specialty products, with an unwavering commitment to patient safety and care. As a patient-oriented and rapidly growing organization, we are focused on delivering specialty, value-added sterile injectables that bridge critical gaps in the market by supporting healthcare workers through improved hospital workflows, reduced waste of key resources, and increased operational efficiencies. This facility marks the foundation of our broader vision to become a trusted leader in sterile manufacturing, with plans to swiftly expand our innovative product portfolio to address evolving healthcare needs.

Position Title: Process Equipment Engineer

Location: Branchburg, NJ

Reports to: Head of Operations and Engineering

Purpose Statement:

The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility. This role will play a critical part in ensuring that all manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. Equipment include sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags. Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle.

Key Responsibilities:

1. Lead t he specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, inspection equipment, secondary packaging equipment, and associated support systems.
2. Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.
3. Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.
4. Promote and ensure adherence to safety protocols and safe work practices.
5. Perform risk assessments for engineering and maintenance activities.
6. Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.
7. Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.
8. Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.
9. Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.
10. Identify and implement process improvements to enhance operational safety, efficiency, and reliability.
11. Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.
12. Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.
13. Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.
14. Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.

Qualifications / Experience:

• Bachelor's degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.
• 3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.
• Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.
• Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.
• Experience working in greenfield or major facility expansion projects highly desirable.

Skills / Competencies:

• Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.
• Proven project management skills with ability to handle complex, cross-functional projects.
• Excellent problem-solving abilities and root cause investigation experience.
• Effective communication and vendor management skills.
• Ability to work independently in a fast-paced, startup-like environment.
• Strong teamwork, collaboration, and continuous improvement mindset. xhyhwjd
• High attention to detail with strong commitment to safety, compliance, and product quality.