DP Operations Specialist - Small Molecule Facility Startup

Biopharma Careers; Elkton (KY); On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

Other insurance benefits

Retirement benefits (401k)

Paid holidays

Vacation

Job summary

Merck is seeking an experienced DP Operations Specialist to support the commissioning, qualification, start-up, and readiness of a new Small Molecule facility in Elkton, VA. You will coordinate with Operations, Engineering, Quality, and Technical teams to ensure safe, compliant plant start-up and continuous improvement across IPT workstreams.

Join a team focused on operational excellence, lean implementation, and standard work to drive efficient manufacturing, process optimization, and

Qualifications

• Minimum 5 years of experience in Drug Product/SDI manufacturing, including operations and technical operations.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Ability to work effectively across Operations, Engineering, Quality, and Technical teams.

Responsibilities

• Support commissioning, qualification, start-up, and operational readiness for the new DP Small Molecule facility.
• Partner with Operations, Engineering, Quality, Technical Operations, and Supply Chain for safe, compliant start-up.
• Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization.
• Support technology transfer and implementation of commercial manufacturing processes into the new facility.
• Define, implement, and improve operating practices, standard work, procedures, and routines for reliable operations.
• Coordinate and prioritize improvement activities within the IPT to meet business goals.
• Utilize Production System tools and lean principles to identify improvement opportunities.
• Embed best practices across shifts, functions, and workstreams for efficiency and consistency.
• Promote a culture of safety, quality, compliance, and continuous improvement.
• Act as a delegate for the Production Lead when needed.

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

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

Tools

Kaizen

5S

Standard Work

Job description

Merck is seeking an experienced DP Operations Specialist to support the commissioning, qualification, start-up, and readiness of a new Small Molecule facility in Elkton, VA. You will coordinate with Operations, Engineering, Quality, and Technical teams to ensure safe, compliant plant start-up and continuous improvement across IPT workstreams.

Join a team focused on operational excellence, lean implementation, and standard work to drive efficient manufacturing, process optimization, and