Technical Operations Specialist-2 at MSD

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. At the Durham Vaccine Facility in Durham North Carolina the Global Vaccine Technology & Engineering (GVTE) Team is seeking candidates to fill IPT Engineering positions to partner with Manufacturing Operations Quality Operations and Process Automation. GVTE provides technical engineering and manufacturing support for the production of our Companys live virus vaccines at Durham.Position Description:We currently have an exciting opportunity for an Engineer to join our vaccine manufacturing Technical Operations department within out Companys Manufacturing Division supporting a sterile fill finish lyophilization vaccine manufacturing facility in Durham NC. This state of the art facility started in 2004 is manufacturing our Companys lifesaving vaccines. Due to the importance of this facility in our Companys Vaccine Manufacturing Supply Chain the facility has seen rapid growth in production volumes and new employees over the last several years.The IPT (Integrated Process Team) Support Specialist will be part of a cross functional team charged with the technical support of the manufacturing shop floor in a fill-finish vaccine facility. This role requires the ability to execute multiple projects and activities across the IPT. Strategic and effective communication and collaboration skills are essential. The successful candidate will also have robust problem solving skills and a hands-on approach to equipment validation and problem solving with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement.Primary ResponsibilitiesSupporting the Cap and Inspect equipment area by analyzing complex processing problems through critical analytical thinking and on the floor troubleshootingDevelopment of sound scientific justification for planned material and process and equipment changesWorking with the Operations Automation and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause implement corrective actions complete trending analysis and determine product dispositionPreparing and/or providing guidance and review for regulatory filings process descriptions investigations and change requests. Acts as a participant in domestic and international regulatory agency inspectionsSupporting all quality and safety initiativesProvide technical support to manufacturing shop floor for in-process analytics controls and troubleshootingKeeping the supervisor current on the progress of projects and making improvement recommendations on production proceduresSupport on shift support during critical manufacturing runs such as Aseptic Process Simulation protocol execution and developmental runsResponsible for authoring process change controls and completing tasks to implement Drug Product equipment/process changes.Serve as a technical writer for Quality NotificationsProvide technical support for the design machinability evaluation process performance qualification and qualification of new or modified equipment componentsPosition Qualifications:Education Minimum RequirementsBachelors degree in an Engineering or Science Related fieldRequired Experience and SkillsMinimum two (2) years post-bachelors degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations or militaryStrategic and effective communication leadership and teamwork skillsPreferred Experience and SkillsOptimizing and troubleshooting aseptic processing operations such as formulation filling lyophilization or automated inspection processesFamiliarity with process risk assessment tools Quality by Design principles and Lean/Six Sigma methodologiesOur Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities along with our external contractors suppliers and partners create an interdependent global manufacturing network thats committed to delivering a high quality reliable supply to customers and patients on time every time.Required Skills: Accountability Accountability Adaptability Change Control Management Collaborative Communications Corrective Action Management Data Analysis Equipment Troubleshooting GMP Compliance Good Manufacturing Practices (GMP) Hardware Implementation Healthcare Innovation Leadership Lean Manufacturing Multi-Management Personal Initiative Process Automations Process Optimization Process Simulation Professional Integrity Project Management Quality Assurance (QA) Standards Quality Assurance Processes Quality Operations Risk Assessments 5 morePreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:EEOC Know Your RightsEEOC GINA SupplementWe are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.Learn more about your rights including under California Colorado and other US State ActsU.S. Hybrid Work ModelEffective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.The salary range for this role is$85600.00 - $134800.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive if applicable.We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring OrdinanceSearch 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:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:12/25/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Required Experience:IC Key Skills Financial Services,Information Technology,Cost Control,Corporate Risk Management,Law Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 85600 - 134800