Specialist, Engineering at Merck Sharp & Dohme Corp. /Netherlands

Upper Gwynedd Township, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

134800.0

Posted On

06 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Guidelines, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices, Manufacturing, Personal Initiative, Process Engineering, Production Support, Standard Operating Procedure Writing, Sterile Manufacturing, Sterile Procedures, Teamwork, Technical Writing, Troubleshooting, Deviation Investigations, Mammalian Cell Culture

Industry

Pharmaceutical Manufacturing

Description

Job Description Specialist, Engineering Our company is seeking a highly motivated Specialist, Engineering to join our Technical Operations Deviation Management team within our manufacturing division at the West Point site. This role is crucial in providing engineering technical support for live virus bulk vaccine production. If you are passionate about driving innovation and ensuring the highest standards in vaccine manufacturing, we invite you to join our team and contribute to our mission of saving and improving lives around the world. The primary responsibility of the individual will be investigation initiation and closure associated with manufacturing deviations and development of actions in response to these deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/equipment actions, and other related duties. This position will require development of technical expertise of process and product knowledge. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. Responsibilities Lead and/or work as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Manage the IPT deviation management daily huddle to evaluate potential deviations, facilitate discussions to align with technology and quality approvers/representatives on deviation classification and impact assessment. Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to understand and resolve the root cause. Support and/or execute continuous improvement projects that increase compliance, simplify/standardize, and/or gain efficiencies. Manage timelines to ensure key compliance and customer due dates are met; escalate any potential misses and develop remediation plans when possible. Assure consistent application of standardized work, engineering, and process tools. Provide technical support to manufacturing shop floor for problems and issues. Conduct and design experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale. Author and update technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control, and validation. Collaborate effectively with area Technicians, support groups, and Quality. Qualifications Required B.S. degree in Engineering or Sciences. Minimum one (1) year post-bachelor’s degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with less than 1 year experience). Demonstrated ability to drive results. Strong communication and collaboration skills and ability to drive accountability. Strong problem-solving skillset. Preferred Experience in vaccine manufacturing. Experience in sterile processing. Technical writing experience (e.g., investigations, technical protocols/reports). Familiarity with investigative tools (e.g., 5-whys, fishbone). Experience authoring investigations for atypical events in a manufacturing setting. Experience with BSL-2 Processing. Required Skills: cGMP Guidelines, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing, Personal Initiative, Process Engineering, Production Support, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Sterile Procedures, Teamwork, Technical Writing, Troubleshooting Preferred Skills: Deviation Investigations, Mammalian Cell Culture 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. 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: EEOC Know Your Rights EEOC GINA Supplement 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. 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, 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”. The salary range for this role is $85,600.00 - $134,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (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 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: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): some Job Posting End Date: 12/19/2025 *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:R375487

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Responsibilities

The Specialist will lead and participate in deviation investigations to prevent recurrence, including root cause analysis and corrective action recommendations. They will also provide technical support to manufacturing and manage compliance timelines.