Job Description

Job Description

The Specialist is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of our manufacturing operations, located at Our Companies Teknika facility in Durham, North Carolina. This Individual will provide leadership as the senior automation engineer for an aseptic manufacturing facility. Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups. Supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automation technologies and make a positive impact. Provides direct support to Automation Lead including leading cross functional teams and providing direct guidance to the Automation team. Also provides technical coverage on automated systems.

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.

Primary Activities include, but are not limited to:

* Understands and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations. Review and approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.

* Leads investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.

* Evaluates automated and information technology systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade.

* Assists in the Automation Lead in the training, development, motivation, and assignments for employees and contractors.

* Coordinates projects with staff group for timely implementation.

* Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems.

* Participates in audits and training programs in the area of responsibility.

* Project coordination leadership and implementation of troubleshooting activities and change control.

* Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.

* On-floor support of manufacturing activities.

* Identify and implement process/equipment improvements and manufacturing efficiencies.

* Serves as liaison with corporate and divisional automation and IT groups.

Position Qualifications:

Education Minimum Requirement:

* B.S., B.A., or greater preferably in Engineering, Science, or Information Technology

Required Experience and Skills:

* Minimum 2 yrs. in process automation or equivalent.

* Experience programming PLCs (e.g., ladder logic), HMIs, and SCADA (e.g., iFix, Indusoft)

* Computer system validation and Systems Development Life-Cycle methodology experience

Preferred Experience and Skills:

* Experience working with Information Technology teams.

* Minimum 3 yrs. of aseptic processing/sterile manufacturing experience.

* Experience with regulatory audits and working knowledge of data integrity principles.

* Understanding of Lean Manufacturing /Six Sigma methodology.

* Strong leadership, interpersonal and communication skills.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are

We are known as Merck & Co., Inc., Kenilworth, 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

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R96899