Project Engineer

Discover International; Frankfurt; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Discover International is seeking a Project Engineer to support sterile manufacturing projects across Europe. The role bridges engineering, vendors, construction, commissioning and client stakeholders in regulated pharma environments.

You will coordinate across process, mechanical, clean utilities, HVAC, automation and CQV teams, supporting design reviews, FAT/SAT, and project handover while ensuring GMP compliance and risk management. Travel will be required.

Qualifikationen

• Experience in pharmaceutical/biotech life sciences projects.
• Experience with sterile/aseptic facilities and GMP environments.
• Strong coordination and stakeholder management skills.

Aufgaben

• Support project delivery for sterile fill-finish facilities.
• Coordinate engineering activities across process, mechanical, clean utilities, HVAC, automation, CQV and construction teams.
• Support technical delivery of vial filling areas and related systems (isolators/RABS, lyophilisation, capping, packaging).
• Manage project documentation, queries, actions, schedules and deliverables.
• Review design documents, vendor packages and constructability inputs.
• Coordinate vendors, contractors and client stakeholders.
• Support FAT/SAT, installation, commissioning and CQV readiness.
• Ensure alignment with GMP Annex 1, EHS and client requirements.
• Track risks, changes and milestones; provide progress updates.

Kenntnisse

Pharma engineering

Project coordination

GMP knowledge

Vendor coordination

CQV

Cleanroom design

Aseptic filling

HVAC/utilities

German language

English language

Jobbeschreibung

We are supporting an international engineering organisation delivering complex pharmaceutical and biotech projects across Europe and globally. The business is looking for a Project Engineer to support the delivery of sterile manufacturing projects, with a strong focus on aseptic fill-finish, vial filling, cleanrooms, GMP utilities and process equipment integration. This role is suited to someone who can bridge engineering, vendors, construction, commissioning and client stakeholders within regulated pharmaceutical project environments.

Responsibilities

• Support project delivery for sterile fill-finish and aseptic manufacturing facilities.
• Coordinate engineering activities across process, mechanical, clean utilities, HVAC, automation, CQV and construction teams.
• Support technical delivery of vial filling areas, isolators/RABS, washing/depyrogenation, lyophilisation, capping, visual inspection and packaging interfaces.
• Manage project documentation, technical queries, action tracking, schedules and engineering deliverables.
• Review design documents, equipment layouts, URS, vendor packages and constructability inputs.
• Coordinate vendors, contractors, internal engineering teams and client stakeholders.
• Support FAT/SAT, installation, commissioning, qualification readiness and handover activities.
• Ensure project execution aligns with GMP, Annex 1, EHS, quality and client requirements.
• Track risks, changes, milestones and technical issues throughout project delivery.
• Provide clear progress updates to project leadership and support issue resolution on site.

Requirements

• Project engineering experience within pharmaceutical, biotech or life sciences engineering projects.
• Experience working on sterile, aseptic, fill-finish, vial or GMP manufacturing facilities.
• Understanding of cleanroom construction, hygienic design, contamination control and classified areas.
• Knowledge of fill-finish equipment such as vial filling lines, isolators/RABS, lyophilisers, depyrogenation tunnels, cappers, inspection or packaging systems.
• Good understanding of GMP utilities including WFI, clean steam, purified water, compressed air, process gases and HVAC.
• Experience working with EPCMV teams, equipment vendors, contractors and client-side stakeholders.
• Ability to support design, construction, commissioning and CQV interfaces.
• Strong coordination, documentation and stakeholder management skills.
• Fluent German and English required.
• Willingness to travel for project requirements.

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