Associate Director, Automation Engineering

Merck & Co.•Rahway, NJ

40d•Hybrid

About The Position

Primary Responsibilities: Maintain and support facility automation and controls to ensure robust operation and compliance with GMP, safety, data integrity, and current regulatory expectations Provide automation leadership for GMP clinical manufacturing campaigns and pilot plant operations, including ongoing system support and troubleshooting Manage, develop, and grow a team of 8-10 OT/Automation engineers; oversee objectives, employee development, resource planning, and budget preparation Lead design, scoping, implementation, and GMP closeout of pilot plant projects; specify and integrate automation for new equipment, upgrades, and improvements Serve as the site automation representative for new capital projects; initiate and provide resources for technical support, and direct coordination of startup, commissioning, qualification, and validation activities Collaborate with IT, GES, OEMs, and cross-functional teams to evaluate and implement new technologies and automation systems that improve reliability, efficiency, and performance Receive assignments, direction, and technical guidance from leadership and/or Pharmaceutical Sciences colleagues; actively contribute within multidisciplinary, cross-functional teams and cross-train across areas and technologies Author, review, and approve GMP procedures and documentation, including SDLC/CSV deliverables, engineering drawings, change controls, SOPs, test protocols, safety reviews, and deviation investigations/actions Develop and execute qualification and validation plans for automated computer systems; prepare and approve protocols and summary reports; execute commissioning and decommissioning Facilitate and participate in QN reporting, investigations, and CAPA; support QMS activities, periodic reviews, and equipment/system changes Solicit, share, and implement best practices with peers; promote continuous improvement and reliability maintenance best practices Exercise objectivity in reporting findings; demonstrate cooperative, responsive collaboration; uphold personal and workplace safety Maintain strong knowledge of cGMPs, financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory requirements; provide technical, project management, and systems leadership

Requirements

BS in Engineering Science, or Information Systems, plus a minimum of 7 years of related technical support or manufacturing automation experience or acceptable related experience.
Highly motivated, adaptable, and effective in fast-paced, dynamic environments; able to work independently and as part of a team
Strong leadership, project management, organizational, and communication skills; proven ability to mentor individuals and influence cross-functional groups
Demonstrated technical proficiency and troubleshooting across mechanical, electrical, and automation domains; experienced supporting capital projects
Prior automation experience in GMP pharmaceutical/biopharmaceutical/vaccine operations, including executing GMP change controls and adhering to Quality, cGMP, Safety, Environmental, and data integrity policies
Significant hands-on experience in one or more automation technologies, including PLCs (e.g., Allen-Bradley, Siemens) and SCADA (e.g., iFIX, WinCC OA, Ignition)
System administration and lifecycle management for automated and digital systems: Programmable Logic Controllers (PLCs), Supervisory Control and Data Acquisition (SCADA) and Batch operations aligned to S88/S95 Information Technology (IT) infrastructure/interfaces
Ability to flex and “flow to the work,” supporting both Quality and Facility needs to meet business priorities
System administration and management of the following automated systems: Programmable Logic Controllers Supervisory Control and Data Acquisition systems Distributed Control Systems Batch Operations (S88/S95) Manufacturing Execution Systems Information Technology OEM equipment.
Accountability
Analytical Thinking
Budget Formulation
Business Management
CAPA Investigations
Communication
Cross-Cultural Awareness
Data Integrity
Deviation Management
Driving Continuous Improvement
Engineering Principle
Engineering Standards
Environmental Safety
General Safety
GMP Compliance
Maintenance Supervision
Manufacturing Quality Control
Manufacturing Scale-Up
Multidisciplinary Collaboration
Multi Disciplinary Design
People Leadership
Pilot Plant Operations
Professional Engineering
Project Management

Nice To Haves

Able to work independently and lead or facilitate tasks; manages work directly or indirectly through projects
Strong understanding of business impact and prioritization of technical initiatives; experienced in building and planning technology roadmaps
Experienced with project management methodologies (Agile, Waterfall) and tools (MS Project, RACI, Gantt)
Hands-on experience with manufacturing equipment and process control; automation infrastructure design and cybersecurity awareness
Skilled in integrating equipment automation with enterprise IT systems (MES, virtualization, networking) and managing Windows/antivirus patching and updates
Experience supporting GMP audits

Responsibilities

Maintain and support facility automation and controls to ensure robust operation and compliance with GMP, safety, data integrity, and current regulatory expectations
Provide automation leadership for GMP clinical manufacturing campaigns and pilot plant operations, including ongoing system support and troubleshooting
Manage, develop, and grow a team of 8-10 OT/Automation engineers; oversee objectives, employee development, resource planning, and budget preparation
Lead design, scoping, implementation, and GMP closeout of pilot plant projects; specify and integrate automation for new equipment, upgrades, and improvements
Serve as the site automation representative for new capital projects; initiate and provide resources for technical support, and direct coordination of startup, commissioning, qualification, and validation activities
Collaborate with IT, GES, OEMs, and cross-functional teams to evaluate and implement new technologies and automation systems that improve reliability, efficiency, and performance
Receive assignments, direction, and technical guidance from leadership and/or Pharmaceutical Sciences colleagues; actively contribute within multidisciplinary, cross-functional teams and cross-train across areas and technologies
Author, review, and approve GMP procedures and documentation, including SDLC/CSV deliverables, engineering drawings, change controls, SOPs, test protocols, safety reviews, and deviation investigations/actions
Develop and execute qualification and validation plans for automated computer systems; prepare and approve protocols and summary reports; execute commissioning and decommissioning
Facilitate and participate in QN reporting, investigations, and CAPA; support QMS activities, periodic reviews, and equipment/system changes
Solicit, share, and implement best practices with peers; promote continuous improvement and reliability maintenance best practices
Exercise objectivity in reporting findings; demonstrate cooperative, responsive collaboration; uphold personal and workplace safety
Maintain strong knowledge of cGMPs, financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory requirements; provide technical, project management, and systems leadership