Full 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.
Our company is expanding its global recombinant human papillomavirus (HPV) 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 HPV 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 Senior Specialist Shop Floor Hardware / Bench-top Equipment serves as a Subject matter expert supporting the (computerized) systems and peripherals used to access automation and IT systems and support automated Bench-top Laboratory equipment that directly supports Durham site manufacturing, while actively supporting, participating in and embracing an empowered team culture.
The Senior Specialist Business Consulting must be able to work independently and be comfortable reaching across functional and geographical areas to collaborate with IT colleagues, third party solution providers and contractors.
Requires Subject Matter Expert (SME) level knowledge and experience in Software Development Life Cycle (SDLC) documentation for computerized Shop Floor Hardware and automated bench-top laboratory equipment in a regulated environment.
Builds knowledge of the company, processes and clients and/or customers
Solves a range of Shop Floor hardware and bench-top equipment issues in a regulatory compliant manor
Responsible for effective document review and conformance to our Manufacturing Division Quality Policies, current Good Manufacturing Practices (cGMPs) for the generation and approval of the required documentation and testing.
Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.
Develops, reviews and approves site procedures and reviews updates to divisional guidelines.
Responds to divisional initiatives and Quality Directives.
Analyzes possible solutions using standard procedures
Receives a minor level of guidance and direction
Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
Understands the fundamental business drivers for the company; and uses this knowledge in own work
Understands and applies regulatory / compliance requirements
The Shop Floor Hardware / Bench-top Equipment Support will be responsible for supporting the manufacturing shop floor hardware and bench-top equipment at the Durham site including the following:
Providing technical leadership for the assigned area and system(s) to ensure a compliant and reliable supply of product and on time project execution with production shop floor support as needed.
Providing leadership and technical support including authoring or review of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control, System Development Life Cycle (SDLC) documents, and other key automation related processes.
Developing, reviewing and approving of department Standard Operating Procedure's ( SOPs) and other site Good Manufacturing Practices (GMP) Standard Operating Procedure (SOPs) related to automation and digital activities and adheres to established quality standards.
Leading 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.
Leading the proper maintenance and operation of tablets, desktops, laptops, peripherals, printers, scanners, production phones and communications equipment, and local network connections for computer equipment (including benchtop and portable automated equipment) used in the manufacture of product in Good Manufacturing Practices (GMP) manufacturing facilities, included in classified space.
Lead the definition, Software Development Life Cycle (SDLC) documentation and validation execution of new computerized and automated equipment that supports manufacturing.
Reviewing system and Software Development Life Cycle (SDLC) documents, preventive maintenance, and Standard Operating Procedure (SOPs) to ensure compliance with Good Manufacturing Practices (GMP) and safety.
Providing Software Development Life Cycle (SDLC) documentation support for current Good Manufacturing Practices (cGMP) and non-cGMP business applications, including (but not limited to):
Production: MES, PAS-X, SAP, Citrix, My-Apps, GLIMS, Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms
Supports validation documentation hardware installation, troubleshooting and repair of PSU, RAM, hard drives, motherboards, touch screens, POS devices, Tablets, ELO touch screens, bar code Scanners, badge readers, and Printers.
Support Account administration for service accounts, machine accounts group administration (MES, admin groups for workstation and server administration) for tablets, desktops, and laptops used in Good Manufacturing Practices (GMP) manufacturing facilities.
Participating in site and department tier structure, leading a tier meeting for Full time employees( FTEs) supporting shop floor hardware.
Evaluating automated and information technology systems, and developing strategies to optimize and ensure quality and stability of these systems through future expansion, replacement, or upgrade. Interacts with above-site IT groups to align solutions with current corporate IT platform and guidelines.
Leading investigations of problems and anomalies and implement corrective actions to prevent recurrence.
Participating in audits and training programs in the area of responsibility.
Developing, maintaining, and reporting metrics to trend problems and identify solutions.
Leading contract employees to provide the above, in compliance with safety and current Good Manufacturing Practices (cGMP) procedures.
Managing vendors and contract employees for conduit, network drop, and equipment installations, and incursion management for work in classified space, coordinating with the Quality unit.
Other duties requested by Management.
Reports to the Associate Director, Manufacturing Automation
Frequent interaction with employees from other departments
Standard Operating Procedure (SOP) development and review.
Direct support of validation activities and all other associated Quality functions.
Other duties requested by Management.
Interacts with representatives from regulatory agencies and external suppliers
Uses existing procedures to solve routine or standard problems
Applies limited judgment and discretion
INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:
Responds to standard requests from clients and/or customers
Accountable for technical contribution to project team or sub-team; may manage/lead a small project team
Aware of costs and assists in controlling costs related to own work
Education Minimum Requirement:
Bachelor's Degree in Engineering, Science, Information Technology or other relevant discipline
Required Experience and Skills :
Minimum five (5) years of experience in a production regulated industry
Minimum of five (5) years of experience in a Good Manufacturing Practices (GMP) manufacturing automation related role and direct experience with Software Development Life Cycle (SDLC) and change controls.
Subject matter expert knowledge level knowledge and experience in computerized Shop Floor Hardware and automated bench-top laboratory equipment in a regulated environment.
Demonstrated ability to build relationships with team, peers and area leads.
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.
High personal integrity, credibility, and energy.
Excellent communication and influencing skills.
Strong written and verbal communication skills in English.
Preferred Experience and Skills: in GMP manufacturing, and OEM equipment.
experience in a Good Manufacturing Practices (GMP) manufacturing automation related role and direct experience with Software Development Life Cycle (SDLC) and change controls.
Direct experience with all levels of the S95 model from ERP to shop floor instrumentation and working knowledge of S88
Data Integrity Acumen
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.
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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