Project Engineer (m/f/d)
OC Recruitment GmbH & Co. KG
Contact person: Patrik Androsevic
Wien, Austria
Medicine and PharmaceuticalsEngineering ManagementEngineering SupportPharmaceutical EngineeringProject Engineering
Description
Our client is looking for a highly qualified Freelance Strategic Project Engineering Consultant to support the Peptide Downstream Facility Vienna (PDFV) project, a strategic CAPEX initiative focused on planning and implementing new peptide production capacities within an existing pharmaceutical facility.
The consultant will work across multiple engineering disciplines, including Process, Equipment, Piping, CSA, HVAC, Clean Utilities, Electrical, Automation, BIM, CQV, EHS, Operations, and Maintenance. The assignment requires a highly autonomous engineering expert with strong pharmaceutical CAPEX experience who can independently develop and deliver structured engineering management frameworks, technical review documentation, registers, progress reports, and decision-support materials.
Tasks:
Develop and maintain a project-specific Engineering Management Plan, including engineering strategy, planning phases, review gates, workflows, and multidisciplinary engineering work packages.
Structure and coordinate engineering activities across Process, Equipment, Piping, CSA, HVAC, Clean Utilities, Electrical, Automation, BIM, CQV, EHS, Operations, and Maintenance.
Establish and maintain an Engineering Deliverables Register and evaluate engineering progress, workload, schedules, critical paths, costs, and changes.
Prepare consolidated engineering progress, schedule, cost, and change reports, including deviation analyses and technically justified recommendations.
Review and validate PURS/User Requirements, Basis of Design (BoD), scope boundaries, design criteria, and technical requirements for completeness and consistency.
Develop structured review concepts and technical documentation for Design Reviews, Constructability Reviews, BIM/Model Reviews, and Value Improvement Reviews.
Create and maintain Engineering Interface Registers covering engineering disciplines, vendors, packages, and existing plant interfaces.
Structure and evaluate Technical Queries, RFIs, Design Comments, Deviations, and engineering changes.
Assess technical changes and alternative solutions regarding scope, safety, EHS, GMP compliance, technical feasibility, and cost impact.
Evaluate vendor and package documentation, including technical bid evaluations, vendor document reviews, and engineering interface clarification.
Prepare technical engineering documentation and decision materials for Gate Reviews, Steering Committees, procurement decisions, and investment approvals.
Perform final engineering completion reviews, including As-Built documentation, interface closure, and engineering handover status.
Prepare the final Engineering Completion Report and ensure structured handover of all agreed technical deliverables and documentation.
Qualifications:
University degree in Process Engineering, Pharmaceutical Technology, Mechanical Engineering, Chemical Engineering, Biotechnology, or a related engineering discipline.
Minimum 5 years of relevant experience in pharmaceutical, biotechnology, process engineering, or plant engineering CAPEX projects.
Proven experience in Front-End Loading phases, particularly FEL2 and FEL3, as well as detailed engineering design for pharmaceutical or biopharmaceutical facilities.
Strong experience coordinating multidisciplinary engineering packages across Process, Equipment, Piping, CSA, HVAC, Clean Utilities, Electrical, Automation, BIM, CQV, EHS, Operations, and Maintenance.
Hands-on experience with Engineering Management Plans, Engineering Deliverables Registers, Interface Registers, Technical Queries/RFIs, Deviation Logs, and Change Registers.
Strong expertise in requirements and design review processes, including PURS/User Requirements, Basis of Design, scope definition, Constructability Reviews, BIM/Model Reviews, and technical decision documentation.
Solid working knowledge of GMP requirements and EHS standards within pharmaceutical plant engineering environments.
Experience evaluating technical vendor bids, vendor document packages, engineering packages, and technical interfaces is highly desirable.
Strong analytical skills with the ability to assess engineering progress, critical paths, cost impacts, risks, changes, and technical alternatives.
Ability to work independently and autonomously on defined engineering work packages without operational integration into daily line management.
Excellent written and spoken German and English skills.
Availability for approximately 30–50% capacity throughout the FEL2/FEL3 project duration.
Preferred: Experience in peptide manufacturing, downstream processing, purification facilities, or comparable biopharmaceutical production environments.
Preferred: Knowledge of LM.VM 2023 engineering performance frameworks.
Preferred: Experience with BIM/3D CAD review tools, Primavera or MS Project, and engineering/document management systems.