Senior Specialist, Operations - (Drug Product)

Merck; Elkton (VA); On-site; USD 96,200 - 151,400; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) plan

Paid holidays

Vacation

Sick days

Job summary

Merck in Elkton, Virginia, seeks a DP Operations Engineer to support the DP/SID integrated IPT in commissioning, qualification, startup, and readiness of a new Small Molecule manufacturing facility. You will partner with Operations, Engineering, Quality, and Supply Chain to ensure safe, compliant startup and smooth technology transfer.

The role emphasizes operational excellence, troubleshooting, and continuous improvement across shifts and functions, embedding best practices for efficient

Qualifications

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline.
• Minimum 5 years of experience in Drug Product/SDI manufacturing, operations, technical operations, or a related manufacturing environment.
• Experience working in a cross-functional manufacturing, technical, or operational setting.
• Experience contributing to operational improvement, troubleshooting, process support, or start-up-related activities.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Strong problem-solving, communication, collaboration, and organizational skills.
• Ability to work effectively across Operations, Engineering, Quality, and Technical teams.
• Ability to prioritize work in a dynamic, fast-paced environment.
• Demonstrated commitment to safety, operational excellence, and continuous improvement.

Responsibilities

• Support commissioning, qualification, start-up, and operational readiness activities for the new DP Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to support safe, compliant, and effective plant start-up.
• Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization activities.
• Support technology transfer and implementation of commercial manufacturing processes into the new facility.
• Help define, implement, and improve operating practices, standard work, procedures, and routines that support reliable and compliant operations.
• Coordinate and prioritize improvement activities within the IPT in alignment with business objectives and operational performance goals.
• Use MPS tools and lean principles (Kaizen, 5S, visual management, Standard Work) to identify and support improvement opportunities.
• Embed best practices across shifts, functions, and workstreams to promote consistency, efficiency, and strong operational execution.
• Support a culture of safety, quality, compliance, accountability, and continuous improvement.
• Act as a delegate for the Production Lead when needed, supporting continuity of leadership and cross-functional coordination.
• Contribute to an inclusive, collaborative, and performance-driven work environment.

Skills

Adaptability

Analytical Problem Solving

Biopharmaceutical Industry

cGMP Compliance

Data Analysis

Decision Making

GMP Compliance

Inventory Management

Lean Management

Lean Process Improvements

Lean Six Sigma Continuous Improvement

Manufacturing Environments

Manufacturing Operations

Manufacturing Technologies

Operational Excellence

Pharmaceutical Manufacturing

Pharmaceutical Process Engineering

Process Improvements

Process Optimization

Production Planning

Production Scheduling

Technical Acumen

Technology Transfer

Education

Bachelor's degree in Chemical Engineering

Job description

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Reports To

Production Lead, DP&SDI

Job Purpose

The DP (Drug Product) Operations Engineer supports the DP and SDI Integrated Product Team (IPT) in the commissioning, qualification, start-up, and operational readiness of the new Small Molecule manufacturing facility in Elkton, Virginia. This role partners with cross-functional teams to help ensure safe, compliant, and efficient operations during project execution and through ongoing manufacturing. In addition, the DP Operations Engineer helps coordinate and prioritize improvement activities and areas of focus across the IPT, supporting continuous improvement and operational excellence as the facility transitions into routine operations.

Primary Responsibilities

• Support commissioning, qualification, start-up, and operational readiness activities for the new DP Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to support safe, compliant, and effective plant start-up.
• Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization activities.
• Support technology transfer and implementation of commercial manufacturing processes into the new facility.
• Help define, implement, and improve operating practices, standard work, procedures, and routines that support reliable and compliant operations.
• Coordinate and prioritize improvement activities and key areas of focus within the IPT in alignment with business objectives and operational performance goals.
• Use our company Production System (MPS) tools and lean principles, including Kaizen, 5S, visual management, and Standard Work, to identify and support improvement opportunities.
• Help embed best practices across shifts, functions, and workstreams to promote consistency, efficiency, and strong operational execution.
• Support a culture of safety, quality, compliance, accountability, and continuous improvement.
• Act as a delegate for the Production Lead when needed, supporting continuity of leadership and cross-functional coordination.
• Contribute to an inclusive, collaborative, and performance-driven work environment.

Minimum Required Education, Experience

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline.
• Minimum 5 years of experience in Drug Product/SDI manufacturing, operations, technical operations, or a related manufacturing environment.
• Experience working in a cross-functional manufacturing, technical, or operational setting.
• Experience contributing to operational improvement, troubleshooting, process support, or start-up-related activities.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Strong problem-solving, communication, collaboration, and organizational skills.
• Ability to work effectively across Operations, Engineering, Quality, and Technical teams.
• Ability to prioritize work in a dynamic, fast-paced environment.
• Demonstrated commitment to safety, operational excellence, and continuous improvement.

Preferred Qualifications

• Experience supporting commissioning, qualification, start-up, or validation activities.
• Experience in a greenfield or new facility start-up environment.
• Experience with technology transfer and implementation of commercial manufacturing processes.
• Experience applying lean tools and methodologies, including Kaizen, 5S, and Standard Work.
• Experience coordinating activities across shifts, teams, or functions.
• Experience serving in a lead, coordinator, or delegate role supporting leadership continuity.
• Experience identifying improvement opportunities and helping implement practical solutions in a manufacturing environment.

This is a unique opportunity to help shape the future of a growing Small Molecule site as it is established from the ground up. In this role, you will support the startup and operational readiness of the new facility, help establish effective ways of working, and contribute to continuous improvement efforts that enable safe, reliable, and high-quality medicine production for patients around the world. If you are a collaborative operations professional with strong technical acumen, a commitment to quality, and a passion for operational excellence, we encourage you to apply. #ELKVACOE

Required Skills

• Adaptability
• Adaptability
• Analytical Problem Solving
• Biopharmaceutical Industry
• cGMP Compliance
• Data Analysis
• Decision Making
• GMP Compliance
• Inventory Management
• Lean Management
• Lean Process Improvements
• Lean Six Sigma Continuous Improvement
• Manufacturing Environments
• Manufacturing Operations
• Manufacturing Technologies
• Operational Excellence
• Personal Initiative
• Pharmaceutical Manufacturing
• Pharmaceutical Process Engineering
• Process Improvements
• Process Optimization
• Production Planning
• Production Scheduling
• Technical Acumen
• Technology Transfer {+ 2 more}

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.

Requirements

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

The salary range for this role is

$96,200.00 - $151,400.00

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.

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.

Employee Status Regular

Relocation Domestic/International

VISA Sponsorship No

Travel Requirements 10%

Flexible Work Arrangements Not Applicable

Shift 1st - Day

Valid Driving License No

Hazardous Material(s) NA

Job Posting End Date

08/8/2026

• 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

R408671