Merck
Associate Director, Technical Operations Automation (Hybrid)
Merck, Lansdale, Pennsylvania, United States
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.
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
Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
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”.
$126,500.00 – $199,100.00
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 We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
01/9/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
#J-18808-Ljbffr
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
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 Skills Current Employees apply HERE
Current Contingent Workers apply HERE
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”.
$126,500.00 – $199,100.00
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 We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
01/9/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
#J-18808-Ljbffr