Spclst , Manufacturing Automation

Job Description

Job Description:

The Specialist, Manufacturing Automation is responsible for supporting the process automation and IT (computerized) systems that directly support vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture.  In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Technical Operations, Operations, Quality, Site Automation, and others.

Position Responsibilities:

Provide technical expertise for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, Automation Installation/Operational qualification.

Partner with cross-functional team to develop automated processes and complete successful qualification of equipment/process.

Support successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility.

Author and update technical documents necessary for automated process design, definition, and qualification.

Maintain automation systems in compliance with cGMPs.

Evaluate automated and information technology systems and develop strategies to optimize and ensure the quality and stability of automation systems through future expansion.

Responsibilities include troubleshooting issues, identifying trends, process monitoring, system administration, update documentation, querying data, operator training and participating in deviation investigations.

Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.

Communicate daily with the business, technical, and quality representatives within the area of support through the tier process.

Support process improvement projects and complex manufacturing investigations.

Support digital and data integrity initiatives for the project.

Provide technical support to manufacturing for complex problems and issues.

Develop and assure consistent application of standardized work, engineering, and process tools.

Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

Develop and manage automation systems standard operating procedures, work instructions.

Responsible for assigned systems alarm and responses and reconciliations.

Support regulatory submission preparation and inspections for the facility.

Education Minimum Requirement:

Bachelor’s degree in an Engineering, Science, Information Technology, or related field OR

Associate's degree in an Engineering, Science, Information Technology, or related field with 2 years of experience in process automation or equivalent OR

High School diploma with 5 years of experience in process automation or equivalent OR

Required Experience and Skills

Minimum 2 years of experience in process automation or equivalent.

Demonstrated a strong performance record and have excellent project management skills.

Highly developed communication, teamwork skills.

Preferred Experience and Skills:

Experience in PLCs (Allen Bradley ControlLogix/CompactLogix, Siemens S7), SCADA, DCSs (Emerson DeltaV), Werum Pas-X MES, Batch Reporting software, OSI PI, ASI/Field/Profibus and other related technologies.

Networking, Virtual Machines, Database management and other general IT administration.

Experience in biologics, vaccine or bulk sterile manufacturing facilities.

Experience with Computer System Validation, new facility start-up.

Regulatory inspection presentation experience with external regulatory authority representatives.

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Required Skills:

Audit Management, Audit Management, Automation, Automation Solutions, Automation Systems, Automation Technology, Business Process Improvements, Change Controls, Competency Management, Computer System Validation (CSV), Data Management, Design Automation, Engineering Standards, Engineering Support, Manufacturing Automation, Manufacturing Systems, Problem Investigation, Problem Management, Quality Management, Real-Time Programming, Site Acceptance Testing, Software Development Life Cycle (SDLC), Systems Automation, System Validation, Team Communication {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$87,300.00 - $137,400.00

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:  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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/28/2026 *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.

Requisition ID:R413333