Senior Specialist, Operations - (Spray Drying)

MSD Malaysia; Virginia (MN); Hybrid; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

MSD Malaysia seeks an SDI Operations Engineer to support the commissioning, qualification, and startup of a new small-molecule facility in Elkton, VA. You will coordinate with Operations, Engineering, Quality, and Technical Operations to ensure safe, compliant startup and smooth transfer of processes.

Responsibilities include providing technical support during start-up, implementing Lean improvements, and driving continuous improvement across IPT while ensuring safety and quality standards are

Qualifications

• Bachelor’s degree in a technical discipline including chemical/biopharma fields.
• Minimum 5 years in Drug Product/SDI manufacturing or related spray drying experience.
• Experience in cross-functional manufacturing environments.
• Experience supporting operational improvements and start-up activities.
• Working knowledge of GMP, quality and compliance in pharma manufacturing.
• Strong problem-solving, communication, collaboration and organization.

Responsibilities

• Support commissioning, qualification, start-up and operational readiness for the new SDI facility in Elkton, VA.
• Collaborate with Operations, Engineering, Quality, and Technical Operations to enable safe startup.
• Provide technical and operational support during equipment start-up and optimization.
• Support technology transfer and implementation of processes into the new facility.
• Define and improve operating practices, standard work, and procedures for compliant operations.
• Coordinate improvement activities and align IPT focus with business goals.
• Utilize Production System tools (Kaizen, 5S, visual management, Standard Work) for improvements.
• Embed best practices across shifts and functions for consistent execution.
• Promote safety, quality, compliance and continuous improvement culture.
• Act as delegate for the Production Lead to ensure leadership continuity.

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

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

Education

Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or related technical discipline

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. Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence. At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

Reports To:

Production Lead, DP&SDI

Job Purpose:

The SDI (Spray Drying intermediate) Operations Specialist 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 SDI 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 SDI 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. Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline. Engineering degree not required.
• Minimum 5 years of experience in Drug Product/SDI manufacturing, operations, technical operations, or a related manufacturing experience in Spray Drying.
• 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.

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

Employee Status:

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: 10/1/2026 *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.

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

Benefits:

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

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.

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.

We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.