Assoc. Specialist, Engineering
Job Summary
As a Process Engineer, you will provide critical support for manufacturing operations within a cGMP environment to drive safety, quality, and process efficiency. You will be responsible for managing deviations, leading minor capital projects, and executing technical initiatives to improve manufacturing performance. The role involves cross-functional collaboration to ensure compliance with engineering standards and regulatory requirements.
Responsibilities
- Provide process engineering support for API manufacturing
- Manage deviations and root cause investigations
- Oversee minor capex projects and system changes
- Conduct technical audits and SOP updates
- Support process safety and energy efficiency initiatives
Required Skills
- Bachelor’s in Chemical/Biochemical Engineering
- GMP and equipment qualification knowledge
- Process Hazard Analysis and FMEA
- Troubleshooting and unit operations
- Project management and cross-functional leadership
Job Details
KEY RESPONSIBILITIES:
- Provide Process Engineering Support for API manufacturing plants to meet Safety, Quality, environmental, and regulatory objectives.
- Support Deviation management related to equipment and systems, including root cause analysis and corrective/preventative actions.
- Manage global change processes to ensure facility and system changes adhere to design and safety standards.
- Lead minor capex projects, including feasibility studies, design, sourcing, installation, and commissioning within budget and timeline constraints.
- Execute portfolio projects introducing new technology and engineering practices for energy efficiency and process safety.
- Provide technical support during quality and safety audits/inspections.
- Conduct gap assessments of business procedures, update SOPs, and provide personnel training.
- Participate in process hazards analyses (PHA) and Process Safety Management (PSM) activities.
REQUIRED QUALIFICATIONS:
- Bachelor’s degree in chemical engineering or biochemical engineering.
- Knowledge of GMP systems, equipment qualification, and commissioning.
- Proficiency in unit operations, equipment maintenance, and troubleshooting.
- Capability to perform Process hazard analysis, FMEA, and Risk assessments.
- Strong project management skills to scope, plan, and execute actions with multi-functional teams.