Sr. Specialist, Engineering

Job Description

Job Description

Our engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, Validation and Process Improvement.-

The Senior Specialist, Vaccines Technology position is responsible for providing technical support to primary filling, inspection, and/or packaging operations within the RotaTeq® Pod vaccine manufacturing facility at the Wilson, NC Site.- This position is for an individual contributor and member of the Technical Team within the RotaTeq® POD Integrated Process Team (IPT).-

This is an engineering role focused on the start-up and commercialization of the vaccine manufacturing facility as well as providing future routine operational support.- This role will act as the technical subject matter expert for all aspects of tech transfer, start up, validation, licensure, and ongoing technical production support for their area of assignment. Primary activities for this position will include, but not be limited to:

Delivery

• Utilize technical expertise, experience, independent judgment, and decision-making to build robust processes that support consistent and reliable supply.
• Lead troubleshooting and optimization activities within the RotaTeq® POD facility
• Lead or support ongoing initial qualification, validation or re-qualification activities
• Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes.
• Provide ownership for Manufacturing Execution System (MES) batch record creation or updates, and facilitate changes as needed to support business needs.

Compliance

• Ensure that assigned processes are developed in a robust manner and defined such that vaccines filled at the Wilson site consistently meet critical quality attributes.
• Act as Technical subject matter expert during regulatory inspections for area of assignment.
• Ensure that process development and validation data is generated and documented in a manner that supports successful licensure and positive interactions with regulatory agencies.
• Execute change management for the RotaTeq® POD IPT and provide scientific/technical justification for proposed changes to support business needs.
• Investigate via the Deviation Management process, determine root cause, and implement robust Corrective Action and Preventive Actions for any process related compliance discrepancies noted during day to day activities and/or audits. -Escalate as per IPT management processes.

Cost

• Ensure that technical startup activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and management-approved timelines are met.
• Recommend continuous improvement, productivity, and capital projects for the IPT.

Continuous Improvement

• Execute projects that support the strategic goals of the IPT.
• Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.

Education Minimum Requirement:

• Bachelor's Degree or higher in Science or Engineering field (Engineering preferred)

Required Experience and Skills:

• Minimum 5 years of relevant industry work experience, with minimum 3 years' experience providing technical / development support to pharmaceutical unit operations
• Demonstrated ability to work independently as team member
• Demonstrated strong interpersonal skills with ability to influence, collaborate, and support others through a culture of inclusion, feedback, and empowerment
• Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
• Willing to work irregular hours to support multi-shift operation on an as needed or extended basis
• Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc.

Preferred Experience and Skills:

• Experience with aseptic filling, qualified inspection processes, or pharmaceutical packaging and serialization/aggregation.
• Experience leading aseptic manufacturing or packaging projects and investigations
• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
• Familiarity with Change Execution Management tools
• Working knowledge of Systems Applications and Products (SAP) and Manufacturing Execution System (MES)
• Experience working in a Center for Biologics Evaluation and Research (CBER) regulated environment
• Demonstrated data analysis skills and experience setting up process control limits (advanced Excel, statistical software packages (Minitab), etc.)
• Experience supporting regulatory inspections including FDA

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Required Skills:
Applied Engineering, Applied Engineering, Business Management Tools, Contractor Oversight, Corrective Action Management, Customer Service, Detail-Oriented, Driving Continuous Improvement, Engineering Design, Engineering Standards, Facility Management, Lean Manufacturing, Lean Product Development, Mechatronics, OSHA Regulations, Pharmaceutical Packaging, Process Engineering, Regulatory Inspections, Regulatory Requirements, SAP Manufacturing Execution (SAP ME), Standard Operating Procedure (SOP) Writing, Technical Problem-Solving, Technology Startups, Utilities Management, Vendor Management {+ 1 more}

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
$106,200.00 - $167,200.00

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 .

You can apply for this role through (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:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
NA

Job Posting End Date:
04/1/2026
*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: R389477