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Job DescriptionOur 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.We have an exciting opportunity for a Senior Specialist, Manufacturing Automation for a capital project start-up in Durham, North Carolina. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.ResponsibilitiesTechnical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of the product and on-time project execution. Provide production shop floor support
Application of sound project management techniques to meet schedule, budget, benefit realization and other project objectives
Provide technical guidance/support including authoring or review and approval of system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other key automation-related processes
Providing direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert
Understands and supports all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety
Assisting in the development and review and approval of department SOPs and other site GMP SOPs related to automation and digital activities and adheres to established quality standards
Develops and supports corrective actions associated with automation related deviations/investigations
Communicates periodically with immediate supervisor about status of area of responsibility
Support digital innovation initiatives on an as-needed basis
Initiate and lead collaboration within the Operations, Quality, and Technical organizations to resolve complex problems
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 | Oversees investigations of automation anomalies to prevent recurrence
On-floor support of manufacturing activities
Identify and implement process/equipment improvements and manufacturing efficiencies
Maintain technical documentation
Working RelationshipsReports to the Associate Director Manufacturing Automation
Frequent collaboration with employees from other departments
Interacts with representatives from regulatory agencies and external suppliers
Education RequirementBachelor degree or higher in Engineering or Computer Science
Experience and SkillsRequiredMinimum five (5) years in a production regulated industry
Minimum of five (5) years 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 Emerson DeltaV 2) | Allen Bradley PLC (or equivalent) | 3) PI (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 our companies Leadership Principles and Enterprise Leadership
High personal Integrity, Credibility, and Energy
Strategic and effective communication and influencing skills both verbal and written
PreferredWorking with Information Technology teams
Regulatory audits and working knowledge of data integrity principles
Understanding of Lean Manufacturing /Six Sigma methodology
Team building and strategic 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 that’s 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., Rahway, 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 APPLICANTSIn 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.Residents of ColoradoClick here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA SupplementOFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Residents of Colorado:Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not SpecifiedShift:Not IndicatedValid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R202836
Vacancy expired!