Project Engineer

Bimeda•Pomona, CA

24d•Onsite

About The Position

The Project Engineer provides technical engineering and project execution support for capital, equipment, facility, utility, infrastructure, remediation, and operational improvement initiatives at Bimeda’s Pomona manufacturing site. This in-office role is a shared site resource, working across Engineering, Maintenance, Operations, QA, MS&T, Validation, EHS, IT, Finance, Procurement, and other functions. The Project Engineer reports to the Plant Manager and supports assigned projects throughout their lifecycle, from feasibility and scope development through technical design, budgeting, procurement, installation, commissioning, qualification support, turnover, and closeout. The role supports Pomona site growth, new manufacturing capabilities, CAPEX execution, facility and infrastructure improvements, aging equipment replacement, and the transfer of additional formulations and manufacturing processes to Pomona. For product and formulation transfers, the Project Engineer partners with the MS&T Process Engineer. MS&T retains process science and technical transfer ownership, while the Project Engineer drives engineering readiness and execution for equipment, facilities, utilities, installation, and commissioning. The position is based in Pomona, California, and works in warehouse and production environments, with possible exposure to noise, chemicals, and machinery. PPE is required in certain areas. The role may require work outside regular hours or on weekends and involves walking, standing, and occasional lifting of up to 50 pounds. The job description is not exhaustive; other relevant duties commensurate with the role may be assigned as priorities evolve.

Requirements

Bachelor’s degree in Mechanical, Chemical, Electrical, or Industrial Engineering, or a related engineering discipline.
Minimum three to five years of engineering, capital project, or manufacturing project experience.
Experience supporting equipment installation, facility or utility projects, commissioning, and manufacturing improvement initiatives.
Demonstrated ability to manage multiple projects, budgets, schedules, vendors, contractors, and cross-functional teams.
Ability to interpret engineering drawings, equipment specifications, vendor proposals, and technical documentation.
Strong project planning, technical problem-solving, communication, organization, and financial management skills.
Ability to manage multiple priorities in an active manufacturing environment.

Nice To Haves

Experience in pharmaceutical, life sciences, medical device, chemical, food, or another regulated manufacturing environment is strongly preferred.
Working knowledge of cGMP, FDA-regulated manufacturing, commissioning, qualification, validation, and change control is preferred.
Experience with project management software and project controls tools is preferred.
PMP or similar project management certification is a plus but not required.

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 costs 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 reports.
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 projects are transitioned to Operations, Engineering, and Maintenance with drawings, manuals, spare parts, PM and CAL requirements, warranties, vendor support, and closeout documentation.
Provide site leadership with clear project status, technical risks, budget concerns, and required decisions.