We are seeking a Process Optimization & Project Engineer to support manufacturing operations, process troubleshooting, and capital project execution within a regulated biotech or pharmaceutical environment. This role applies core engineering principles to optimize systems, resolve operational challenges, and lead small-scale projects from planning through implementation. The ideal candidate will bring strong technical expertise, project coordination skills, and the ability to collaborate across multidisciplinary teams.
Key Responsibilities
- Provide solutions to technical problems of moderate scope and complexity.
- Apply standard engineering techniques and procedures under general supervision.
- Perform assignments with clear objectives and investigate a limited number of variables.
- Act as a technical expert for equipment and systems, supporting troubleshooting and operational continuity.
- Engage in daily operations to meet production schedules and resolve complex issues.
- Conduct audits of equipment performance and regulatory compliance.
- Collaborate with manufacturing, process development, maintenance, QA, validation, utilities, and facilities to define requirements and recommend system modifications.
- Work with manufacturing teams to develop user requirements for capital projects.
- Develop and manage project schedules for installation and qualification activities.
- Coordinate directly with construction and commissioning/qualification (C&Q) contractors to ensure timely delivery of project milestones.
- Administer project implementation and closeout activities.
- Communicate and report project status to site leadership and senior management.
- Monitor contractor progress, address delay claims, and review change orders and invoices.
- Prepare monthly project status reports and maintain project documentation.
- Support C&Q and startup activities for manufacturing facilities and process equipment.
Requirements
Education & Experience
- Bachelor’s degree in Engineering
- Minimum of 2 years of engineering experience
- Preferred disciplines: Mechanical, Electrical, or Chemical Engineering
Technical & Software Requirements
- Experience supporting industrial process equipment in biotech manufacturing environments
- Familiarity with commissioning, qualification, and validation (C&Q) processes
- Ability to operate specialized laboratory equipment and engineering software
- Proficiency in project scheduling tools and documentation systems
Preferred Qualifications
- Experience working directly for a biotechnology or pharmaceutical company
- Knowledge of GMP production operations and regulated environments
- Familiarity with GLPs, GMPs, and validation protocols
- Strong technical writing and documentation skills
- Bilingual proficiency in English and Spanish
- Ability to interface with technical, scientific, and management user groups
Benefits
- Administrative Shift
- 8-months contract with possible extension