Assoc. Spclst, Engineering

Merck KGaA Darmstadt Germany - Durham, NC

Full-time - Entry Level

Onsite - Durham, NC

10,001+ employees

Chemical Manufacturing

About the position

The Associate Specialist in Technical Operations will play a crucial role in supporting the design, development, and manufacturing of sterile products, particularly in the context of drug substance and drug product processing. This position is integral to a capital project aimed at enhancing human health through innovative vaccine and biologic solutions. The role involves collaboration with various teams to ensure operational efficiency and compliance within a state-of-the-art facility in Durham, North Carolina.

Responsibilities

• Independently manage project assignments and escalate potential delays while developing remediation plans.
• Assist with the design, authoring, and execution of protocols for technical transfer using laboratory facilities and production equipment.
• Author and update technical and manufacturing documents necessary for change controls, batch records, and standard operating procedures.
• Provide on-the-floor support for operational and technical issues in the manufacturing environment.
• Support team safety, environmental, and compliance objectives.
• Collaborate effectively with manufacturing coaches, operators, and support groups such as Quality and Planning.

Requirements

• Bachelor of Science (BS) degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or a related engineering discipline.
• Strong communication and teamwork skills.
• Ability to manage projects and work to schedules and deadlines.

Nice-to-haves

• Aseptic cGMP manufacturing experience in biological drug substance or drug product.
• Experience with aseptic process simulations (APS), electronic batch records, and/or change controls.
• Experience using Lean/Six Sigma tools.
• Minimum of 1 year of experience in pharmaceutical operations, technical services, and/or quality operations.

Benefits

• Hybrid work model with three days on-site and two days remote per week.
• Commitment to diversity and inclusion in the workplace.
• Opportunities for career development and growth.