We are seeking a Process/Operations Engineer to support process optimization, troubleshooting, and technical project execution within a dynamic biotech manufacturing environment. This role involves applying engineering principles to improve system performance, support operational excellence, and contribute to cross-functional initiatives. The ideal candidate will bring a strong foundation in chemical engineering, hands-on experience in regulated environments, and a proactive approach to problem-solving.
Key Responsibilities
- Serve as a technical resource for equipment and systems, providing troubleshooting support and operational insights.
- Actively engage in daily operations to meet production schedules and resolve complex issues.
- Conduct routine audits of equipment performance and regulatory compliance.
- Collaborate with cross-functional teams (e.g., manufacturing, process development, maintenance, QA, validation) to define requirements and recommend system modifications.
- Support design and implementation of engineering projects under the guidance of project managers.
- Interface with consultants, architects, and engineering firms to develop standard design documentation.
- Evaluate quotes for equipment modifications or installations and contribute to cost estimates and project schedules.
- Apply standard engineering techniques to investigate and resolve technical problems of moderate complexity.
- Initiate and complete routine technical tasks with clear objectives and limited variables.
- Prepare and present technical reports and documentation in compliance with regulated standards.
Requirements
- Master’s degree in Engineering, OR
- Bachelor’s degree in Engineering with 2+ years of relevant experience
(Chemical Engineering background preferred)
Preferred Qualifications
- Experience in biotech or pharmaceutical manufacturing environments.
- Familiarity with GMPs, GLPs, and validation protocols
- Working knowledge of drug substance manufacturing operations.
- Experience conducting statistical analyses and interpreting technical data.
- Strong problem-solving and applied engineering skills.
- Proficiency in technical writing and basic technical presentations.
Benefits
- 2 year contract with possible extension
- Administrative Shift