SDI Operations Specialist — Start-up & Optimization

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

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