Project Engineer

Abzena•Bristol, PA

14h

About The Position

The Project Engineer plans and executes site capital projects, equipment installations, facility upgrades, and engineering improvements that support Abzena’s operations. The role provides end-to-end project engineering support, from scope definition and business case development through design, procurement, construction, commissioning, qualification, startup, and turnover to operations. The Project Engineer works with Manufacturing, Facilities & Engineering, Quality Assurance, Validation, EHS, Supply Chain, Finance, Process Development, Quality Control, Information Technology, contractors, architectural and engineering firms, and equipment vendors. The position is accountable for delivering technically sound, safe, compliant, and cost-effective solutions while managing project scope, schedule, budget, risk, documentation, and operational readiness. Abzena is a CDMO focused on biologics and bioconjugates, providing services from early discovery through commercial manufacturing. The company emphasizes quality, responsible and efficient delivery, and helping bring treatments to patients.

Requirements

Bachelor’s degree in Mechanical, Chemical, Electrical, Industrial, Biomedical, or another relevant Engineering discipline.
At least 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.
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.

Nice To Haves

Working knowledge of pharmaceutical manufacturing equipment, cleanrooms, HVAC, critical utilities, process utilities, automation, or laboratory systems.
Experience with project scheduling, CMMS, ERP, document management, or project controls systems.
Experience in a CDMO, biologics, ADC, bioconjugation, sterile manufacturing, or other complex GMP manufacturing environment.
Project management certification, Lean/Six Sigma training, or formal project controls experience.

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.
Manage project scope, schedule, budget, forecasts, commitments, change management, and financial tracking.
Coordinate multidisciplinary project teams and establish accountability for milestones, decisions, actions, risks, and deliverables.
Lead or support engineering design and constructability reviews, equipment selection, technical bid evaluations, and vendor selection.
Develop and review technical specifications, equipment requirements, drawings, layouts, P&IDs, utility requirements, and other engineering deliverables.
Manage engineering firms, contractors, construction partners, and equipment vendors to ensure work meets company requirements, approved designs, schedules, 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 qualified before GMP use.
Ensure complete and compliant project turnover, including as-built drawings, manuals, spare parts, preventive maintenance and calibration requirements, training, asset records, and system documentation.
Initiate and support change controls, engineering assessments, deviations, CAPAs, investigations, and risk assessments related to project execution and equipment or facility modifications.
Ensure projects comply with cGMP requirements, Good Engineering Practices, data integrity expectations, applicable codes and standards, and company 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.
Use structured problem-solving and root cause analysis to resolve technical issues during design, installation, commissioning, qualification, and startup.
Develop and maintain project dashboards and KPIs for safety, schedule, cost, scope, risk, quality, and readiness.
Provide routine project status updates to site leadership, 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 and internal audits and regulatory inspections by providing project engineering documentation and technical expertise.
Promote disciplined project execution, strong documentation practices, cross-functional collaboration, and a culture of safety, quality, and accountability.