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Merck · 2 hours ago

Associate Director, Technical Operations Automation (Hybrid)

West Point, PA

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$126K/yr - $199K/yr

7+ years exp

Merck is a leading pharmaceutical company seeking an Associate Director, Automation within Global Clinical Supply. This role is responsible for developing and executing a systems and process automation strategy to support operations and supply technologies, ensuring compliance and effective project execution.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Lead startup of systems-related aspects of new operational facilities and equipment

Lead system-related aspects of new technology deployment such as system development lifecycle (SDLC), assessments of data integrity, privacy, risk, and other aspects necessary for GxP use

Implement automation solutions, including both platform technologies and associated analytics, reporting, and visualization capabilities

Develop and complete appropriate system validation, Change Control and testing documentation, ensuring compliance with all requirements

Support of systems upgrades/maintenance, and new software/systems install

Reviewing automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with Good Manufacturing Practice and safety

Partner with business areas to develop processes to enable use of technology & equipment

Developing and supporting corrective actions for investigations related to automation or IT systems

Conduct or support automation system-related investigations and implement necessary CAPAs

Qualification

AutomationCQV strategiesCGMP complianceSAPOperational ExcellenceStakeholder ManagementCommunicationLeadershipCross-Functional TeamworkDetail-Oriented

Required

Bachelor's degree in information technology, Engineering, Scientific, or related field

At least 7 years of experience in an information technology and/or operations role within the pharmaceutical industry

Experience with pharmaceutical facility and equipment commissioning, qualification, and validation (CQV)

Development and execution of equipment and facility automation-related CQV strategies

Strong compliance mindset and understanding of cGMP, including FDA and EMEA

Works effectively across boundaries to build strong collaborative relations with other groups

Direct support of validation activities and compliance-related requirements functions

Willing to constructively challenge the status quo and explore continuous improvement opportunities

Strong abilities in Stakeholder Management and building and strengthening cross-functional networks

Excellent communication skills

Accountability

Applied Engineering

Automation

Change Management

Combination Products

Communication

Compliance Packaging

Cross-Functional Teamwork

Detail-Oriented

Deviation Management

Engineering Standards

Good Manufacturing Practices (GMP)

IT Operation

Leadership

Manufacturing Scale-Up

Mentorship

Operational Excellence

Packaging Engineering

Performance Monitoring

Pharmaceutical Manufacturing

Preventive Maintenance

Process Optimization

Production Standards

Risk Management

Preferred

Experience with Operational Excellence methodology e.g. Six Sigma and Lean methods principles and tools

Leadership of cross-functional teams through project planning, execution, monitoring, and closeout phases to deliver successful completion to project target milestone dates

Experience with SAP or other production software

Networking, Virtual Machines, Database management and other general OT & IT administration