Project Engineer

Job Title: Project Engineer
Location: Pomona, CA (In-office)
Position Type: Full-time
Vacancy Status: This position is vacant
AI Disclosure in Hiring: We use artificial intelligence to screen, assess and select applicants
Job Summary
The Project Engineer provides technical engineering and project execution support for capital, equipment, facility, utility, infrastructure, remediation, and operational improvement initiatives at the Pomona manufacturing site.
Reporting to the Plant Manager, this position serves as a shared site resource and works across Engineering, Maintenance, Operations, QA, MS&T, Validation, EHS, IT, Finance, Procurement, and other functions.
The Project Engineer will support assigned projects through the full lifecycle, including feasibility, scope development, technical design, budgeting, procurement, installation, commissioning, qualification support, turnover, and closeout.
A key focus of the role will be supporting Pomona site growth, new manufacturing capability, CAPEX execution, facility and infrastructure improvements, aging equipment replacement, and transfer of additional formulations and manufacturing processes into Pomona. For product and formulation transfers, the Project Engineer will work closely with the MS&T Process Engineer. MS&T will retain process science and technical transfer ownership, while the Project Engineer will drive engineering readiness and execution for equipment, facilities, utilities, installation, and commissioning.
Role Specific Requirements
Key Responsibilities
Execute assigned Pomona capital and site projects from concept through completion, managing scope, schedule, budget, risks, actions, and deliverables.
Develop and coordinate feasibility assessments, technical scopes, test protocols, equipment specifications, design reviews, utility requirements, cost estimates, schedules, and CAPEX request support.
Provide technical engineering support for manufacturing equipment, packaging systems, facilities, utilities, infrastructure, Automation, and site improvement projects.
Partner with Engineering, MS&T, and Process Engineering on formulation and process transfers, translating process requirements into equipment, facility, utility, procurement, validation, and production readiness needs.
Coordinate equipment installations, facility modifications, infrastructure upgrades, remediation activities, capacity expansion, Automation upgrades, and aging equipment replacement.
Coordinate engineering firms, equipment manufacturers, contractors, consultants, and vendors, including review of proposals, drawings, technical submittals, and project deliverables.
Track project budgets, actual spending, forecasts, commitments, contingency, change orders, and projected final cost for assigned projects.
Support vendor selection, purchasing, vendor onboarding, long lead equipment, and commercial coordination with Procurement and Finance.
Develop and maintain project schedules, risk registers, action logs, decision logs, and concise status reporting.
Coordinate project activities with QA, Validation, MS&T, Engineering, EHS, and applicable cGMP and change control requirements.
Support FAT, SAT, commissioning, qualification readiness, troubleshooting, training, documentation, and operational turnover.
Plan project work around manufacturing schedules, shutdowns, utility interruptions, and other operational constraints.
Identify and resolve technical issues during project execution using sound engineering judgment, problem solving, and root cause analysis.
Ensure completed projects are properly transitioned to Operations, Engineering, and Maintenance, including drawings, manuals, spare parts, PM and CAL requirements, warranties, vendor support, and closeout documentation.
Provide clear project status, technical risks, budget concerns, and required decisions to site leadership.
Additional Notes:
Working conditions: warehouse and production environments. Exposure to noise, chemicals, and machinery. PPE required in certain areas.
Physical demands: Walking, standing, occasional lifting (up to 50 pounds).
May require work outside regular hours or weekends.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role
EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. Express oneself clearly in verbal and business writing.
FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this, supporting data-driven decision-making and strategic planning.
INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
What We Are Looking For
Qualifications
Education
• Bachelor's degree in Mechanical, Chemical, Electrical, Industrial Engineering, or a related engineering discipline.
Experience
• Minimum three to five years of engineering, capital project, or manufacturing project experience.
• Experience in pharmaceutical, life sciences, medical device, chemical, food, or another regulated manufacturing environment strongly preferred.
• Experience supporting equipment installation, facility or utility projects, commissioning, and manufacturing improvement initiatives.
Skills
• Demonstrated ability to manage multiple projects, budgets, schedules, vendors, contractors, and cross functional teams.
• Working knowledge of cGMP, FDA regulated manufacturing, commissioning, qualification, validation, and change control preferred.
• Ability to interpret engineering drawings, equipment specifications, vendor proposals, and technical documentation.
• Strong project planning, technical problem solving, communication, organization, and financial management skills.
• Experience with project management software and project controls tools preferred.
• PMP or similar project management certification is a plus but not required.
Key Competencies
• Accountability and execution
• Technical judgment and problem solving
• Collaboration and teamwork
• Effective communication
• Planning and organization
• Initiative
• Results orientation
• Ability to manage multiple priorities in an active manufacturing environment
What We Offer
Compensation & Benefits
Health Insurance (medical, dental, vision)
401(k) plan for retirement savings
Paid time off (vacation, sick leave, holidays)
Life insurance
Employee assistance program
About Bimeda

Employment type
Full-time regular

Work arrangement
No