Associate Director, Technical Operations Automation (Hybrid)

Job Description

The Associate Director, Automation within Global Clinical Supply (GCS) is responsible for developing and executing a systems and process automation strategy to support new and existing operations and supply technologies, capabilities, and performance monitoring.  This role will partner regularly with Technical Operations and Capital Projects to ensure the compliant execution of automation-related aspects of our projects.  This role will also lead the execution of projects within Technical Operations and upskill personnel on the basics of automation.

Specifically, this role will:

• 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.

Position Qualifications:

Education Minimum Requirement: 

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

Required Experience and Skills:

• 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

Preferred Experience and Skills:

• 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.

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Required Skills:

Accountability, 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 {+ 4 more}

Preferred Skills:

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US and Puerto Rico Residents Only:

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