Job Description

Are you passionate about automation, quality, and continuous improvement? Do you thrive in a fast-paced, team-oriented environment? If so, we invite you to apply for the position of Manufacturing Automation Specialist at our West Point, PA site - the largest vaccine manufacturing facility in our company,

Job Description:

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The West Point, PA campus is our Company's largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future.

The Building 50 Live Virus Vaccine Filling Facility project team is seeking a highly motivated individual to fill an open position to support the start-up of a new vaccine filling & lyophilization facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and live virus vaccine drug product process demonstration in support of facility licensure.

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

• 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.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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

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".

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R330526