Sr. Reliability Engineer

Job Description

Job Description

The Senior Specialist, Engineering will partner with Quality Operations, Manufacturing Process Systems (MPS), and Engineering to provide technical support for floor operations in a range of capacities ranging from analysis of operating performance, management of key operational data within SAP, application of advanced problem solving capabilities, strengthening compliance posture and inspection readiness, and investigating and authoring deviations related to unplanned events.

The Senior Specialist, Engineering, will perform lead scientific investigations and data analysis to determine root cause, product impact and develop corrective actions for unexpected results.

Primary Activities Primary Activities include, but are not limited to:

• Identify and implement technology-driven productivity improvements.
• Ownership of Quality System Chapters and development of Subject matter expertise.
• Identify and solve a range of problems in complex situations, analyze possible solutions and assess each via standard procedures.
• Demonstrate proficiency developing processes to minimize cost and maintain process consistency.
• Collaborate independently with Engineering Change Management personnel to facilitate execution.
• Manage small/medium scale projects across the Operations area related to changes supporting increased reliability, demonstration
• of new technology, or enhanced compliance.
• Responsible for coordinating, developing and implementing Corrective Action/ Preventive Action (CAPA) plans. Author deviations
• as required.
• Leads trouble-shooting efforts and effectively resolves and author investigations for manufacturing atypical events.
• Develops and implements corrective actions to unplanned (atypical) manufacturing events to ensure consistent and reliable product
• supply.
• Works as part of the deviation reduction team to drive high level corrective actions to automate/eliminate root cause conditions to
• prevent recurrences. Represents operations in deviation reduction meetings/huddles.
• Tracks and trends operating performance (metrics) and works cross-functionally to drive required actions.
• Evaluates worker productivity and recommends improvements to increase manpower efficiency.
• Accountable for technical contribution to project teams and will be expected to manage lead/small projects.
• Demonstrates understanding of Standardized Work principles and identifies targets for implementation within the Operations and
• Business Processes, and develops Standardized Work Instructions to improve training and routine execution of task.
• Engages with the continuous improvement team to drive changes that reduce lead times, improves quality, and mitigates cost.
• Maintain current state data for operational run rates, operational performance (OEE with Reliability Engineering). Utilizes data to
• drive productivity improvement.
• Develop Standardized Work for Operations and Business Processes
• Engages with the continuous improvement team to drive changes that reduce lead times, improves quality, and mitigates cost.

Education Minimum Requirement:

• Bachelor of Science in Engineering field

Required Experience and Skills:

• Minimum of 5 years of relevant industrial experience
• Demonstrated ability to work independently.
• Relevant work experience encompassing a working knowledge of FDA regulatory requirements
• Excellent leadership, strong communication (written and oral), interpersonal and supervisory skills.
• Technical writing knowledge and experience, i.e. documentation of scientific data
• A sound knowledge and/or experience with optimization processes and/or equipment
• Enthusiasm, confidence and the ability to take initiative for continuous improvement and learning Knowledge and/or experience with formal problem solving techniques as it relates to a hands-on approach to problem solving,
• techniques as it relates to a hands-on approach to problem solving

Preferred Experience and Skills:

• Relevant work experience encompassing a working knowledge of FDA regulatory requirements
• cGMP experience in a pharmaceutical packaging environment
• Formal training with Lean Six Sigma tools and certifications
• Knowledge and/or experience with formal problem solving techniques as it relates to a hands-on approach to problem solving, such
• as root cause analysis and/or Lean Six Sigma tools
• Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
• Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols
• Knowledge of SAP

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.

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.

If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:

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OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:R39787