Sr. Chemical Process Engineer

Mallinckrodt Pharmaceuticals - Raleigh, NC

Full-time - Mid Level

Raleigh, NC

Chemical Manufacturing

About the position

The Sr. Chemical Process Engineer will be a key member of the APAP Operations Team, responsible for managing day-to-day production, optimizing plant operations, and resolving operational issues. This role involves providing technical assistance to manufacturing employees to ensure production targets are met while adhering to safety and quality regulations. The engineer will also be involved in training, project implementation, and continuous improvement initiatives within the manufacturing environment.

Responsibilities

• Study processes and equipment to identify problems and opportunities.
• Provide technical guidance and instruction to the APAP Operations Team regarding troubleshooting and debottlenecking efforts.
• Ensure all processes operate within defined and validated limits.
• Conduct training for the APAP Operations Team on new equipment and process changes.
• Represent the APAP Operations Team in developing and implementing capital projects, including project scoping and process controls.
• Prepare periodic reports summarizing production rates, yields, rework status, and quality conditions.
• Identify and implement changes to reduce product costs by increasing production rates and improving equipment efficiency.
• Participate in periodic process audits with management personnel regarding safety, environmental, quality, production, and cost.
• Generate, review, and update documentation for managing the process, including operating reports and batch records.
• Investigate process deviations and coordinate implementation of corrective measures.
• Support site continuous improvement processes and serve on teams to improve workplace efficiency.

Requirements

• B.S. in Chemical or Mechanical Engineering.
• 5-10 years of experience in chemical or bulk pharmaceutical (API) manufacturing operations.
• Knowledge of chemical and chemical engineering principles to solve production, quality, and throughput problems.

Nice-to-haves

• Understanding of GMPs (ICH Q7) and process validation.
• Understanding of Six Sigma and Lean Manufacturing tools and concepts.
• Experience in root cause analysis.
• Experience with change control / management of change.
• Demonstrated technical and leadership skills including oral/written communications and conflict resolution.
• Ability to plan and execute tasks on multiple projects simultaneously.

Benefits

• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities