Durham, NC, 27722, USA
9 days ago
Spclst, Operations
**Job Description** **Job Description:** 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, manufacturing 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. We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of Vaccines and Biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. We have an exciting opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This new facility includes end-to-end processing of drug substance and drug product, including product inspection, warehouse, utilities, and quality control laboratories. The Specialist, Operations will be responsible for providing support to the manufacturing area as part of the Operations team. **Position Responsibilities:** + This role reports to the Operations Director and supports BCG production in Durham, NC. B160 production includes Drug Substance, Drug Product and supporting areas + Management and execution of tasks for B160 operations kanban area. Work with operations leadership to implement and execute standard work + Support and execute operations training program (e.g. oversight of operations job codes, curricula assignments, ILT coordination/execution, etc.) + Support training and execution of day to day SAP transactions + Lead contractor hiring for B160 operations + Collaborate with broad partners and stakeholders across all B160 functions and across site for information + Independently manage project assignments, escalate potential delays and develop remediation plans when applicable + Collaborating across diverse teams + Creating strong safety culture + Contributing to the manufacturing team and support for the facility + Leading routine process support, projects, and improvement activities + Serving as subject matter expert on the process for daily work and projects, understand full process requirements such as safety, compliance, process **Applicant must complete and be medically cleared for BCG medical clearance requirements: questionnaire, blood test, chest x-ray** **Required Experience and Skills:** + Bachelor degree in an Engineering or Science related field with minimum 2 years post-bachelors degree experience in manufacturing, operations, pharma, biotech or vaccines work environment. + OR 1 year of the described experienced and a Master’s degree in an Engineering or Science related field + OR 4 years of the described experience and a High School Diploma + Communication, leadership and teamwork skills **Preferred Experience and Skills:** + cGMP experience in a sterile bulk, biologics or pharmaceutical environment, operations, technical services, supply chain, and/or quality operations + Experience operating in SAP and/or other electronic operating systems + Experience in hiring team members + Experience in training employees, managing training across team members + Experience using Lean, Six Sigma, Operational Excellence tools + Demonstrated ability to work in fast-paced, complex environments and escalate appropriately + Flexibility and ability to manage multiple priorities + Demonstrates interpersonal, technical aptitude and problem-solving skills \#MSJR Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We 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. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) **U.S. Hybrid Work Model** Effective 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 Ordinance **Los 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 Ordinance **Search 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:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 02/28/2025 ***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.** **Requisition ID:** R336547
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