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.
Our company is expanding its global recombinant vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.
Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our company manufactures the two vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.
The Associate Director Manufacturing Automation is responsible for managing the team in Durham, NC facility for the assigned 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.
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
Education Minimum Requirement:
Required Experience and Skills:
Minimum eight (8) years of experience in a production regulated industry (part or all of the eight years providing manufacturing automation services) – OR – Master's or MBA degree with six (6) years' experience – OR – PhD with three (3) years' experience
Two or more years of direct people management experience
Minimum of five (5) years of experience in a GMP manufacturing automation related role and direct experience with SDLC and change controls
Direct experience with at least two of the three platforms 1) Process Automation (DeltaV), 2) PLCs, and 3) PI/InfoBatch (or equivalent)
Demonstrated ability to build relationships with team, peers and area leads
Demonstrated leadership in achieving shared objectives in a matrix organization
Strong understanding of manufacturing principles/ processes and ability to translate manufacturing requirements into Automation/digital solution
Proven track record of analytical skills, problem solving and attention to detail
Able to demonstrate the Company Leadership Principles and Enterprise Leadership
High personal integrity, credibility, and energy
Excellent communication and influencing skills
Strong written and verbal communication skills in English
Preferred Experience and Skills:
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 …
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 …
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.
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