Job Description

　　We are seeking a Growth and Improvement minded Laboratory Operations Engineering Specialist that can help drive our Strategic Operating Priorities.

　　Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic LandscapeDiverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the worldValues and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us

　　Summary, Focus and Purpose

　　The Global Vaccine Biologics Commercialization (GVBC) group within the Manufacturing Division focuses on late-stage process development, technology transfer, and in-line support of vaccine and biologics products. We seek people-oriented leaders with strong laboratory management skills to take a leadership role in the development and commercialization laboratory management activities supporting multiple programs.

　　Key Functions

　　Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | InclusionSupporting development and execution of plans for laboratory start up, including equipment ordering, planning for testing, maintenance, calibration, and qualification.Performing activities to support commissioning and qualification of computerized Analytical and or production systems as per System Development Life Cycle guidelines, updated CFR Data Integrity standards, and other regulatory guidelines.Supporting capital project execution teams for lab renovation projects to ensure project scope alignment with intended lab operational philosophy and lab scale platform needs.Development of tools and schedules to aid process teams in the efficient utilization of lab space.Communicating updates (verbally/written) and presenting to all levels within the organization.Partnering with the business unit in the laboratories, process manufacturing and development areas, various quality sponsored oversight, IT technical promotion, and various software and instrument vendors/manufacturers.Performing any change control during the life cycle of a computerized system.Decommissioning of systems as part of the System Development Life Cycle (validation) guidance.Participating in departmental initiatives and workstreams aimed at improving the way that we work and the way that we interact with one another as well as other departments. Improving business processes to find new efficiencies and connect people to the information that they need.

　　Education

　　Bachelor's degree required; concentration in a scientific or applied discipline preferred.

　　Required Experience | Skills | Knowledge

　　Experience in laboratory start-up environments, operations, or management.Technical understanding of the DP and DS commercialization process.Customer focused mindset with strong written and verbal communication skillsTrouble shooting and problem-solving methodologies.Demonstrated ability to work independently to effectively accomplish goals in a team setting.Ability to self-regulate and prioritize based on communications from management and various project teams (e.g., time management).Ability to author and review specific technical documents including GXP change control, formal SOPs, system validation protocols, etc.

　　Preferred Experience | Skills | Knowledge

　　GMP/GXP environment and compliance expectationsDefining User Requirement Specifications for equipmentLaboratory fit out, start up, commissioning or qualification.2+ years of knowledge participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification)Able to perform validation activities as a self-directed author while conferring with the business, technical, and quality approvers.Authorization to work in the United States indefinitely without restriction or sponsorship.

　　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.

　　Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

　　Current Employees apply HERE

　　Current Contingent Workers apply HERE

　　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 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

　　EEOC GINA Supplement

　　Pay Transparency Nondiscrimination

　　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

　　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, generally Tuesday, Wednesday and either Monday or 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".

　　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:

　　Hybrid

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　n/a

　　Requisition ID:R272716