Lead Biologics Pilot Plant Automation Engineer

Merck & Co.; North Wales (Montgomery County); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k)

Job summary

Merck & Co. is seeking a Senior Specialist, Pilot Plant Automation Engineer to lead automation activities for pilot-scale GMP manufacturing of biologics. The role drives implementation, qualification, and continuous improvement of automation solutions within the pilot plant environment.

Responsibilities include leading projects, authoring GMP documentation, and collaborating with cross-functional teams to ensure reliability and efficiency of manufacturing operations.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related technical discipline.
• Minimum of 5 years of relevant experience, including at least 3 years of automation engineering.

Responsibilities

• Provide technical leadership and ongoing support for facility automation systems.
• Serve as the automation subject matter expert for GMP clinical manufacturing campaigns.
• Lead and/or execute integration, commissioning, qualification, and startup of new equipment and automation projects.
• Author, review, and approve GMP documentation including change controls, test protocols, SDLC, SOPs, safety assessments, deviations and CAPAs.
• Lead maintenance, lifecycle management, and upgrade initiatives for automation systems.
• Evaluate and implement new automation technologies to improve plant reliability and performance.
• Collaborate with cross-functional teams in a multidisciplinary project environment.
• Cross-train across multiple technologies, systems, and processes to expand expertise.

Skills

Automation

GMP

Pilot Plant Ops

Process Optimization

Deviation Management

Equipment Qualification

Device Integration

Equipment Implementation

Strategic Thinking

Technical Problem-Solving

Adaptability

Data Analysis

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Ignition

DeltaV

Job description

Merck & Co. is seeking a Senior Specialist, Pilot Plant Automation Engineer to lead automation activities for pilot-scale GMP manufacturing of biologics. The role drives implementation, qualification, and continuous improvement of automation solutions within the pilot plant environment.

Responsibilities include leading projects, authoring GMP documentation, and collaborating with cross-functional teams to ensure reliability and efficiency of manufacturing operations.