Project Engineer

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

Responsibilities

- Manage assigned capital and expense projects from concept through closeout, including scope development, design, procurement, construction, commissioning, qualification, startup, and turnover.

- Develop project charters, scopes of work, user requirements, project execution plans, cost estimates, schedules, risk registers, and resource plans.

- Own project scope, schedule, budget, forecasts, commitments, change management, and financial tracking for assigned projects.

- Coordinate multidisciplinary project teams and drive clear accountability for milestones, decisions, actions, risks, and deliverables.

- Lead or support engineering design reviews, constructability reviews, equipment selection, technical bid evaluations, and vendor selection.

- Develop and review technical specifications, equipment requirements, drawings, layouts, P&IDs, utility requirements, and engineering deliverables.

- Manage external engineering firms, contractors, construction partners, and equipment vendors to ensure work meets Abzena requirements, approved design, schedule, safety expectations, and GMP standards.

- Plan and support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, commissioning, and qualification activities.

- Partner with Validation and Quality to define risk-based commissioning and qualification strategies and ensure systems are appropriately qualified before GMP use.

- Ensure complete and compliant project turnover, including as-built drawings, manuals, spare parts, preventive maintenance requirements, calibration requirements, training, asset records, and system documentation.

- Initiate and support change controls, engineering assessments, deviations, CAPAs, investigations, and risk assessments associated with project execution and equipment or facility modifications.

- Ensure projects comply with cGMP requirements, Good Engineering Practices, data integrity expectations, applicable codes and standards, and Abzena quality systems.

- Integrate EHS requirements into project design and execution, including contractor safety, permitting, job hazard assessments, lockout/tagout, and safe startup.

- Coordinate project activities with site operations to minimize disruption to manufacturing, laboratories, utilities, warehouses, and other critical functions.

- Plan and execute work during shutdowns, maintenance windows, and off-hours when required to protect manufacturing schedules and business continuity.

- Support equipment and facility lifecycle planning by identifying reliability risks, obsolescence, capacity constraints, and improvement opportunities.

- Apply structured problem-solving and root cause analysis to resolve technical issues encountered during design, installation, commissioning, qualification, and startup.

- Develop and maintain project dashboards and KPIs covering safety, schedule, cost, scope, risk, quality, and readiness.

- Provide routine project status updates to site leadership, clearly communicating progress, decisions required, emerging risks, budget status, and recovery plans.

- Support annual capital planning, project prioritization, business case development, and long-range site investment planning.

- Identify opportunities to improve project delivery, engineering standards, equipment reliability, operational efficiency, capacity, and compliance.

- Support client audits, internal audits, and regulatory inspections by providing project engineering documentation and technical subject matter expertise.

- Promote disciplined project execution, strong documentation practices, cross-functional collaboration, and a culture of safety, quality, and accountability.

Qualifications

- Bachelor's degree in Mechanical, Chemical, Electrical, Industrial, Biomedical, or other relevant Engineering discipline required.

- Minimum 3 years of project engineering, capital project execution, facilities engineering, process engineering, or related experience in pharmaceutical, biotechnology, life sciences, or another highly regulated manufacturing environment.

- Demonstrated experience supporting projects through multiple lifecycle phases, including design, procurement, construction, commissioning, qualification, startup, and turnover.

- Working knowledge of cGMP requirements, Good Engineering Practices, Good Documentation Practices, data integrity principles, and pharmaceutical quality systems.

- Experience with commissioning and qualification activities, including FAT, SAT, IQ, OQ, and risk-based qualification approaches.

- Experience with change controls, deviations, CAPAs, engineering assessments, and risk management in a regulated environment.

- Working knowledge of pharmaceutical manufacturing equipment, cleanrooms, HVAC, critical utilities, process utilities, automation, or laboratory systems preferred.

- Experience developing or reviewing URS documents, scopes of work, technical specifications, drawings, P&IDs, and vendor documentation.

- Demonstrated ability to manage project budgets, schedules, forecasts, vendors, contractors, and competing priorities.

- Strong technical writing, analytical, troubleshooting, organizational, and structured problem-solving skills.

- Strong communication and stakeholder management skills with the ability to influence and coordinate cross-functional teams without direct authority.

- Proficiency with Microsoft Office applications. Experience with project scheduling, CMMS, ERP, document management, or project controls systems preferred.

- Experience in a CDMO, biologics, ADC, bioconjugation, sterile manufacturing, or other complex GMP manufacturing environment preferred.

- Project management certification, Lean/Six Sigma training, or formal project controls experience preferred.