Bio Process Operations Technician

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 BioProcess Technician is responsible for providing shop floor operations and environmental monitoring support to the aseptic manufacturing areas of the manufacturing facility at the Wilson, NC Site. Responsibilities will include direct operational support for manufacturing activities including formulation, CIP/SIP, packaging, inspection and aseptic primary filling. This position will also be responsible for performing various supporting roles within the facility such as executing routine room and equipment disinfection and managing the movement of gowning, disinfectants, and materials to support the manufacturing areas. In addition to supporting operations activities, the role will be responsible for ensuring that EHS and GMP compliance is maintained within their area of assignment.This position will be an individual contributor and member of the Operations team within the integrated process team (IPT).Primary Responsibilities DeliveryExecute manufacturing operations, environmental monitoring, and facility disinfection within the Pod vaccine manufacturing facilitySet up and operate vaccines formulation, CIP/SIP, aseptic primary filling, packaging, inspection and additional support equipment within qualified parametersIdentify potential equipment problems and partner with other Vaccines Maintenance Technicians to ensure appropriate resolutionDemonstrate ability to troubleshoot process, electronic systems and equipment for routine and basic problemsPerform other duties as requested by the Operations coachCompliance Responsible for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE)Execute operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)Complete documentation in batch records, electronic logs, or other systems in accordance with site procedureMaintain good housekeeping and 5S in assigned work areaAdhere to the highest level of data integrity while performing dutiesIdentify potential quality or safety issues. Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementationCostEnsure that startup activities for area of assignment are executed such that project deliverables and timelines are metClosely monitor team / process performance and improve reliability through problem solving and continuous improvementSet up and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discardsIdentify and help implement continuous improvement and productivity enhancements within the IPTTeam Partner with Technicians and cross-functional support groups for assigned area to maintain an inclusive and positive work environmentDemonstrate a high degree of maturity and personal integrity. Strictly adhere to all site policies on personal conduct and attendanceTrain, develop, and mentor other team members to share experience and best practicesPursue knowledge and skills in assigned area from an operations perspective and share that information readily with teamMaintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solvingRoutinely demonstrates leadership and conflict-resolution ability. Demonstrates a willingness to provide and receive constructive feedback in 360° performance reviewEducation Minimum RequirementHigh School diploma or equivalent and previous experience operating, maintaining, troubleshooting, and/or repairing industrial equipment is preferred | Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates such as Bioworks preferredRequired Experience and Skills Three or more years in a GMP manufacturing facility (aseptic GMP environment strongly preferred)Ability to work independently as Team memberInterpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowermentLeadership ability, peer training experience, and/or productivity improvement activities strongly preferred.Ability to gown and work in an aseptic environmentAbility to work with computerized and automated systemsWilling to work irregular hours to support multi-shift operation on an as needed basisPreferred Experience and Skills Aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operationsWorking in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industryContinuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologiesSAP/MES/electronic log book basic knowledge from a production execution perspectiveAbility and drive to work autonomously and help organize priorities and work with other team membersOutstanding communication skills both within direct team and across multiple shifts to ensure success of overall teamAbility to support technical writing of documents such as standard operating procedures (SOPs)#MSJRVETJOBSRequired Skills: Accountability, Accountability, Analytical Problem Solving, Biological Manufacturing, Biopharmaceuticals, Biopharmaceutics, Cleanroom Gowning, Computer Literacy, Data Integrity, Documentations, Environmental Monitoring, Global Manufacturing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Healthcare Innovation, Laboratory Processes, Lean Manufacturing, Machinery Operation, Manufacturing, Manufacturing Quality Control, Packaging Operations, Pharmaceutical Manufacturing, Production Operations, Production Scheduling { 4 more}Preferred Skills: Current Employees applyCurrent Contingent Workers applyUS 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 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 characteristics. As 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:We 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 another’s thinking and approach problems collectively.U.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 presence.This 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”.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 Carefully
Merck & 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: No Travel RequiredFlexible Work Arrangements: Not ApplicableShift: 3rd – NightValid Driving License: NoHazardous Material(s): N/AJob Posting End Date: 11/7/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

MSD