Senior Automation Specialist - Pharmaceutical Operations Engineering

Job Description

The Senior Automation Specialist in the Rahway Pharmaceutical Operations Engineering organization will be responsible for supporting/maintaining process automation systems in clinical manufacturing. This position may provide direct support to automation compliance, security and obsolescence initiatives or serve as the site automation representative on new capital projects.

General support responsibilities include:

• Work closely with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support.

• Responsible for the successful implementation of Automation solutions, including both platform technologies and associated reporting needs.

• Ensure automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with Current Good Manufacturing Practices(cGMP).

• Support process automation inquiries during internal and external audits/inspections and must, therefore, be able to communicate knowledgeably about automation, process, and cGMP details of clinical manufacturing operations.

• Accountable for implementing process automation system changes and conducting system investigations.

• Develop and complete appropriate process automation system validation, Change Control and testing documentation.

• Develop and support corrective actions for investigations related to process automation/OT or IT systems.

• Active and engaged participation in the site tier processes (routine operations support processes) as well as supporting a culture of continuous improvement at the site.

• Provide on-floor support of clinical manufacturing activities and troubleshooting challenging equipment/automation issues to improve clinical manufacturing performance.

• Provide support as a representative of or lead a team providing technical assistance in fulfilling the automation requirements for the team.

• Review automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with cGMP and safety.

• Ensure automation documents, preventive maintenance, periodic reviews, and SOPs are continuously in an inspection-ready state.

• Develop of a suite of reporting, analytics and visualization solutions that support local clinical operations and administrative business processes.

• Use technical knowledge to assure the efficient operation of a variety of automated operational processing and informational technology systems.

• Participate in audits and training programs in area of responsibility.

• Supervise, schedule and coordinate activities of contract automation engineers and outside contractors/vendors.

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

• Lead in installation and qualification of new equipment into operations.

• Familiar with lean manufacturing principles with an ability to convert business logic and requirements into detailed system requirements.

Skill Requirements:

• Demonstrated strong interpersonal skills with an ability to influence and support others through a culture of inclusion, feedback, and empowerment.

• Allen Bradly PLC, Siemens PLC, WinCC OA SCADA, Ignition SCADA, OPC, ASI/Field/Profibus and other related automation technologies.

• Programming experience including Ladder Logic, Sequence Function Charts, Python, and/or other scripting languages.

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

• Standard Operating Procedure development and review.

• Direct support of validation activities and all other associated Quality functions.

• Applies general knowledge of company business developed through education or past experience

• Understands and applies regulatory/compliance requirements relative to their role

• A problem solver/troubleshooter, skilled in Root Cause Analysis (RCA)

• Knowledge of all of the details of automation including wiring, electrical, device selection and integration

Education Requirements:

• B.S., B.A. in Engineering, Science, Information Technology or related field with 5+ years of experience

• M.S with relevant experience

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

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:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R191927