Associate Director, Technical Operations Automation (hybrid)

Associate Director, Automation

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.

Required Skills:

• Accountability
• Applied Engineering
• Automation
• Change Management
• Communication
• 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 Skills:

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• US and Puerto Rico Residents Only:
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• As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
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• U.S. Hybrid Work Model
• Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
• This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
• Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
• The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
• You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
• San Francisco Residents Only:
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• Los Angeles Residents Only:
• We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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• Employee Status:
• Regular
• Relocation:
• No
• VISA Sponsorship:
• No
• Travel Requirements:
• 10%
• Flexible Work Arrangements:
• Hybrid
• Shift:
• Not Indicated
• Valid Driving License