Job Description

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 Associate Director Manufacturing Automation, is responsible for management for the assigned Durham, NC facility/area process control systems, while actively supporting an inclusive team culture.

Responsibilities may include but are not limited to;

* Directing the technical activities of a professional staff to achieve facility business objectives with on the production shop floor support as needed
* Providing technical leadership for the assigned area and systems to ensure a compliant and reliable supply of product and on time project execution
* Providing direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert
* Leading individual and team development through approved HR guidance and practices, while maintaining staffing at the agreed upon level any by actively engaging in efforts to recruit talent that supports a diverse and inclusive culture
* Providing guidance on system activities to the Integrated Process Team (IPT) leadership team with overall accountability for team and system performance within area of responsibility
* Providing guidance and ensuring that the team follow established standards, principles and governance;
* Providing technical guidance/support for key review and approval of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control, and other key automation related processes
* Assisting in the development and review and approval of department SOPs and other site GMP SOPs related to automation and digital activities
* Supporting problem solving practices to identify and resolve technical and operational problems; able to collaborate with peers to resolve problems that cross into inter-related units
* Adapting and implementing area plans and priorities based on IPT scorecard to address local business challenges
* Other duties requested by Management.

Qualifications

Education Minimum Requirements:

* Bachelors Degree or higher in Engineering or Computer Science

Required Experience and Skills:

* Bachelors or Master of Science in Engineering, Science, Information Technology, or other relevant discipline.
* Minimum eight (8) years of experience in a production regulated industry (part or all of the eight years providing manufacturing automation services) OR Masters or MBA degree with six (6) years experience OR PhD with five (5) years experience in any role.
* Minimum of five (5) years of experience in a GMP manufacturing automation related role and direct experience with SDLC and change controls and direct experience with at least three of these five automation/MES platforms: DCS (preferably DeltaV), HMI/PLCs (preferably Rockwell or Siemens), MES (preferably PAS-X), Data Historian/Batch reporting (preferably PI), Benchtop/laboratory automation
* Experience with GAMP and Data Integrity Principles (ALCOA) and their practical implementation.
* Strong written and verbal communication skills in English.
* Demonstrated leadership in achieving shared objectives in a matrix organization.
* Demonstrated capability in leadership of projects and teams.
* Ability to prioritize and align work to deliver business outcomes.

Preferred Experience and Skills:

* 2+ years experience managing employees in a direct role.
* Experience implementing and using data analytics.
* Direct experience with all levels of the S95 model from ERP to shop floor instrumentation and working knowledge of S88
* Travel: 10% of the time

Working Relationships:

* Reports to the Director Manufacturing Automation
* Manages and interacts with employees within own department
* Frequent interaction with employees from other departments
* Interacts with representatives from regulatory agencies and external suppliers

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:

10%

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R94077