Senior Project Engineer
Syner-G · Oceanside, California, United States · remote
COMPANY DESCRIPTION:
A career here is life-enhancing.
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Synergbiopharma.com
POSITION OVERVIEW:
Syner-G is seeking a Senior Project Engineer to support capital projects at a large pharmaceutical manufacturing facility utilizing both single-use and stainless-steel processing systems.
The Senior Project Engineer will provide owner-side engineering and project execution support for facility, utility, infrastructure, and manufacturing-support projects. Typical projects may include HVAC, cleanrooms, process and plant utilities, cooling towers, electrical systems, laboratory and manufacturing-area modifications, equipment installations, and facility upgrades.
The role will coordinate engineering design, procurement, construction, commissioning, and turnover activities while serving as a key interface between site Engineering, Facilities, Manufacturing, Quality, contractors, vendors, and external design partners.
KEY RESPONSIBILITIES:
- Manage multiple facility and infrastructure capital projects from scope development through design, construction, startup, and turnover.
- Support projects involving HVAC, electrical systems, clean utilities, plant utilities, cooling towers, manufacturing infrastructure, laboratories, and facility modifications.
- Develop project scope, technical requirements, budgets, schedules, procurement plans, and execution strategies.
- Serve as the owner-side engineering interface with design firms, contractors, vendors, and internal stakeholders.
- Review and approve engineering drawings, specifications, shop drawings, submittals, RFIs, equipment packages, and other technical deliverables.
- Provide technical responses to requests for information and coordinate resolution of field and design issues.
- Contribute to technical design of facility equipment, utilities, and associated infrastructure.
- Coordinate process, mechanical, electrical, structural, architectural, HVAC, plumbing, automation, and construction interfaces.
- Confirm equipment layouts, utility requirements, facility interfaces, and installation requirements.
- Support equipment and system procurement, vendor evaluations, technical bid reviews, and contractor coordination.
- Participate in FAT, SAT, commissioning, qualification, startup, and turnover activities as applicable.
- Coordinate construction activities, shutdown work, tie-ins, equipment installations, and work within active GMP manufacturing areas.
- Develop and maintain project schedules, cost forecasts, action logs, risk registers, and project status reports.
- Monitor project costs, commitments, forecasts, change orders, and contractor performance.
- Support development and implementation of Facility Control Plans and other project-specific execution controls.
- Collaborate on project-related change controls, deviations, CAPAs, and GMP documentation.
- Support preventative maintenance, asset turnover, spare-parts planning, and integration with site maintenance systems.
- Identify technical, schedule, cost, safety, and operational risks and drive mitigation and resolution.
- Ensure projects consider constructability, maintainability, operability, safety, GMP requirements, and future facility needs.
- Support development and execution of commissioning and qualification strategies for new and modified facility, utility, and equipment systems.
- Coordinate FAT, SAT, commissioning, startup, IQ/OQ, and turnover activities with Engineering, Validation, Quality, Facilities, Operations, vendors, and contractors.
- Review and support development of commissioning plans, qualification protocols, test scripts, turnover packages, and associated technical documentation.
- Ensure design, installation, commissioning, and qualification activities remain aligned with URS, design requirements, GMP expectations, and project milestones.
- Track and resolve commissioning punch-list items, discrepancies, deviations, and qualification issues through closure.
- Support system handoff from construction and engineering into validated and operational use.
- Coordinate with Validation/CQV teams to ensure projects are designed and executed with qualification requirements considered early in the project lifecycle.
- Support change control, validation impact assessments, and documentation associated with equipment, utility, and facility modifications.
QUALIFICATIONS AND REQUIREMENTS:
Education:
- Bachelor’s degree in Chemical Engineering, or related technical discipline.
Technical Experience:
- 5-7+ years of project engineering, facilities engineering, capital-project, or construction experience.
- Experience supporting pharmaceutical, biotechnology, medical-device, or other regulated manufacturing environments.
- Demonstrated experience managing multidisciplinary facility or utility projects.
Knowledge, Skills, and Abilities:
- Ability to interpret engineering drawings, specifications, P&IDs, equipment layouts, electrical one-lines, and construction documents.
- Experience coordinating engineering firms, contractors, equipment vendors, and internal site stakeholders.
- Strong project controls experience including schedule, budget, procurement, forecasting, and risk management.
- Working knowledge of GMP project execution, change control, commissioning, qualification, and turnover.
- Strong communication, problem-solving, and stakeholder-management skills.
Preferred Experience
- Large-scale pharmaceutical or biologics manufacturing facilities
- Single-use and stainless-steel manufacturing environments
- HVAC and cleanroom systems
- Cooling towers, chilled water, steam, compressed air, and other plant utilities
- Purified water or clean utility systems
- Electrical infrastructure
- Facility shutdowns and tie-ins
- Construction management
- Commissioning / CQV / Validation Support
- Laboratory and manufacturing-area renovations
- Equipment installation and startup
- Project cost forecasting
- RFIs, submittals, shop drawings, and design reviews
- CMMS / asset-management systems
- Commissioning and qualification
- Owner’s-representative or site project-engineering experience
ESSENTIAL FUNCTIONS:
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