Specialist, Engineering - Automation Engineer

Job Description

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

General Summary:
The Automation Engineer is a member of the Plant Engineering team providing technical support to the Durham Site. This support position will focus on leading automation systems compliance and daily ownership of utility system automation controls, system improvements and optimizations. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent reoccurrence and help assess the impact on operations. The incumbent will also be responsible for assisting and leading plant engineering’s automation improvement projects and implementation of productivity enhancement initiatives.

General Profile:

• Individual contributor role working with Staff and Technician employees and/or contractors.
• Contributes to the performance and results of the department.
• Decisions are guided by policies, procedures and business plan; receives guidance from manager.
• Provides technical guidance to employees, colleagues or contractors
• Team member for small capital projects for plant engineering
• Ensures utility system operations daily priorities.
• Support / lead utility automation equipment related projects, scope including funding, change control, integration, commissioning, and equipment qualification
• Obtains bids, reviews contracts, supervises, and follows-up on contract work including.
• Participates in and contributes to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns
• Coordinates with Engineering and IPT production planners
• Attends daily shutdown meetings ensuring owned activities are tracked and completed
• Perform Automation Change control – Hold design review meetings, Create Test Protocols and execute, update SOP’s, update drawings, update SDLC of automation systems, Responsible for historian software updates.
• Responsible for resiliency and modernization of controls systems
• Responsible for inventory accountability of automation systems.
• Responsible for incident reports during adverse events
• Responsible for generation of regulatory compliance reports – Weekly, monthly, annually, and per audit request.
• Responsible for creating BAS accounts for new users, maintain/ensure BAS accounts are accurate and up-to-date.
• Train and provide technical support for new BAS users, assist in setting up Siemens training for new users

Business Expertise:

• Applies skills to align work activities with department objectives
• Project management (manages project priorities – schedule & cost, installation)
• Industrial experience involving utility system generation, distribution and controls are needed. Engineer must have experience working with industrial electrical distribution (low/medium voltages), HVAC/R systems, WFI, clean steam, utility generation equipment, and automation (BAS) systems.
• Must be aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)

Functional Expertise:

• Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency
• Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, GVTE (Global Vaccine Technology), Automation, and Quality approvers.
• Perform a thorough review of engineering records and related GMP documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process from an automation perspective.
• Knowledge of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions.

Problem Solving:

• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
• The successful candidate must have strong problem solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause.
• Responsible for assisting in the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes.
• Assist with trouble shooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLC/HMI’s, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators.
• Perform engineering task as needed to maintain automation of plant utilities equipment.

Impact:
Influence

• Explains difficult concepts and persuades others to adopt point of view.
• Communicates information, asks questions and checks for understanding

Accountability

• Accountable for the performance of plant engineering systems and maintenance concepts

Decision Making

• Makes decisions – guided by policies, guidelines, and procedures – that impact the department’s ability to meet performance objectives
• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Strategic Planning:

• Consults on an as-needed basis with next-level manager for newly identified priorities
• Follows operating strategy from a utility perspective supporting site reliability initiatives.

Working Relationships

• Reports to Plant Engineering Manager
• Frequent interaction with employees from other departments
• Interacts with representatives from regulatory agencies
• Collaborates with the production area maintenance technicians and engineers to maintain utility uptime for all production equipment
• Identifies revisions, deletions, or additions to the automation systems and calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures and no adverse automation events occur.
• Helps establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities
• Assists in deviation investigations for maintenance instruments, equipment, and systems.

Education minimum Requirement:

• Bachelor's Degree in Engineering, Science or related field

Required Experience and Skills:

• Two years of experience in a production and/or calibration and/or maintenance, Automation, Engineering background and/or project management background
• Familiarity and knowledge programming and operating PLC's and HMI's
• Strong planning, scheduling, and time management skills
• Knowledge of regulatory requirements in accordance with GMP manufacturing operations
• Good oral and written communication skills
• Familiarity with GMP compliant calibration and maintenance databases
• Experience with formal problem solving techniques, such as Root Cause Analysis (RCA), Failure Mode Effects Analysis (FMEA, and/or Lean Six Sigma tools)
• Familiarity of "World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.)
• Familiarity understanding of the automation functionality of all utility generation equipment (e.g. electrical distribution, clean utilities - wfi/clean steam, HVAC/R, and utility generation equipment
• Utility and HVAC system process improvement and optimization experience for controls systems
• Technical writing and deviation investigation experience
• Experience in problem solving and troubleshooting
• Familiarity with cGMPs and vaccine regulatory requirements

Preferred Experience and Skills:

• Project management, including change control and equipment qualification
• SAP experience related to plant maintenance and spare parts procurement systems
• Siemens Apogee/Desigo, Rockwell Allen Bradley PLC/HMI experience
• cGMP experience in a sterile, bulk or finished pharmaceutical environment
• Experience in automation and manufacturing execution systems (MES), process modeling and process improvement
• Mechanical functionality and reliability knowledge (asset management)
• Lean Six Sigma/ Green Belt/Black Belt Certification

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for ...

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:MAI000937