Senior HPAPI Process Engineer - Capital Projects & Startup

Merck; Rahway (NJ); Presencial; USD 117.000 - 184.000; Jornada completa

Descripción de la vacante

Merck in Rahway, NJ is seeking a Senior Specialist in Process Design, Execution and Startup for Small Molecule HPAPI containment projects. You will lead capital project design, ensure safety and regulatory compliance, and collaborate with IPT, Engineering Firms, and Vendors to deliver end-to-end solutions.

The role emphasizes technical startup, commissioning, and qualification, with travel up to 50% and on-site support in Rahway.

Formación

• Minimum 5 years in pharmaceutical/biotech engineering or manufacturing.
• Strong knowledge of API manufacturing processes and potent compound containment.
• Experience with hazard analysis, process safety, and cGMP.

Responsabilidades

• Interface with IPT members in support of capital project delivery.
• Lead technical design workshops with End Users to develop Equipment URS.
• Assess multiple options and select a leading approach.
• Core knowledge should include unit operations, PFD/ID development, Hazard Analysis, electrical classified design, equipment design and operation, commissioning & qualification.
• Perform technical reviews of the A&E-generated PFDs and P&IDs to ensure they meet corporate standards and safety needs.
• Participate in PHA/HAZOP/LOPA sessions, ensuring process deviations are addressed in the P&ID design.
• Act as the primary interface between capital projects and Equipment Vendors.
• Adhere to Project Change Control principles to prevent scope creep while maintaining design integrity.
• Familiarity with API operations, chemical handling, process safety, and HPAPI containment controls.
• Lead and collaborate with contractors, suppliers and team members in the execution of the work.
• Drive design of process equipment as Package Owner or Suite Lead; collaborate with Engineering Firms and Vendors.
• Lead Factory Acceptance Testing, Commissioning and Qualification activities.
• Lead peer reviews for assigned Packages and participate across projects.
• Maintain knowledge of best practices and industry trends; participate in professional organizations.
• Participate in development and review of core documents such as procedures and standards.

Conocimientos

Pharma/Biotech experience

Process Design

Containment/HPAPI

GMP Compliance

Cross-functional Leadership

Change Control

Technical Transfer

Project Coordination

Educación

Bachelor of Science in Chemical Engineering

Descripción del empleo

Merck in Rahway, NJ is seeking a Senior Specialist in Process Design, Execution and Startup for Small Molecule HPAPI containment projects. You will lead capital project design, ensure safety and regulatory compliance, and collaborate with IPT, Engineering Firms, and Vendors to deliver end-to-end solutions.

The role emphasizes technical startup, commissioning, and qualification, with travel up to 50% and on-site support in Rahway.