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

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Change Control Management, Data Analysis, GMP Compliance, Good Manufacturing Practices, Lean Manufacturing, Personal Initiative, Process Improvements, Project Management, Regulatory Inspections, Root Cause Analysis, Standard Operating Procedure, Technical Writing, Vaccine Manufacturing, Writing Technical Documents

Industry

Pharmaceutical Manufacturing

Description

Job Description The West Point Technical Operations organization is seeking a highly motivated individual for a Specialist – Engineering position within the Building 12 Varicella Bulk team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing technical guidance and anticipating customer needs to identify and implement solutions. The Specialist, Technical Operations is responsible for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture. In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Operations, Quality, Automation, Maintenance and others. Additional responsibilities include: Provides technical support for Varicella bulk manufacturing at our Company's West Point location to align with department, site, and franchise objectives. Provides on-the-floor support for complex operational and technical (process/equipment) issues. Leads or works as a team member on projects to improve the performance of our processes, including complex investigations, corrective/preventative actions (CAPAs) and equipment validation/qualification. Develops and authors technical and manufacturing documents for investigations, process design/definition/qualification/validation, change control, annual product reviews, standard operating procedures (SOPs), batch records, and preventative maintenance. Monitors the health of the process through continuous process monitoring, communicating observations proactively to stakeholders. Prepare documentation to support regulatory submission and participate in regulatory inspection activities for the facility. Applies a continuous learning mindset to maintain a high level of technical process and system knowledge, enabling success with core responsibilities. Manages project work to ensure due dates are met, escalating when necessary and developing remediation plans. Assures consistent application of standardized work, engineering and process tools. Promotes open communications and teamwork. Effectively collaborates with cross-functional peers. Supports safety, environmental, and compliance initiatives. Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges. Education Minimum Requirement: B.S. degree in Engineering or Sciences. Minimum 2 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations Required Experience and Skills: Strong problem-solving skills. Developed communication, leadership and teamwork skills. Ability to manage projects/work to ensure timely completion. Preferred Experience and Skills: Experience in change control and/or deviation management and/or equipment support and/or project support role. Experience in biologics, vaccine or bulk sterile manufacturing facilities. Understanding of sterile and aseptic processing Required Skills: Change Control Management, Data Analysis, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Personal Initiative, Process Improvements, Project Management, Regulatory Inspections, Root Cause Analysis (RCA), Standard Operating Procedure (SOP), Technical Writing, Vaccine Manufacturing, Writing Technical Documents Preferred Skills: 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: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a 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:R375809

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Responsibilities

The Specialist will provide technical support for vaccine manufacturing unit operations and work on projects to improve process performance. Responsibilities include on-the-floor support for operational issues, leading investigations, and developing technical documents.