Validation Project Manager

Oxford Global Resources; Amsterdam; On-site; EUR 73,000 - 78,000; Full time

Benefits offered by this job

12 month contract

Possibility to extend

Salary €6,500–€7,000 gross monthly

Amsterdam region

Job summary

Oxford Global Resources is seeking an experienced Engineering Project Manager to oversee capital engineering projects in a regulated biopharmaceutical manufacturing setting. You will drive the full project lifecycle from concept through implementation and transfer to operations, coordinating equipment, facilities and utilities with engineering specialists and operations teams.

You will manage schedules and risks, lead cross-functional groups, ensure adherence to cGMP and GAMP standards, and

Qualifications

• 5+ years of project management experience in a cGMP environment.
• Engineering background with BSc or MSc.
• Familiarity with validation and qualification processes (GAMP).
• Experience using PM tools and frameworks (PMP, CAPM, PRINCE2).
• Experience with equipment lifecycle activities (FAT, SAT, IQ, OQ, PQ).

Responsibilities

• Manage Capital Projects in a biopharmaceutical firm
• Lead projects focused on manufacturing equipment, facilities, and utility lifecycles
• Coordinate multidisciplinary teams to achieve project milestones and deliverables
• Perform feasibility studies
• Continuous risk analysis, mitigation and improvement
• Create and present project updates to stakeholders and management

Skills

Project management

cGMP

Stakeholder coordination

Education

BSc or MSc in Engineering

Tools

PMP

CAPM

PRINCE2

Job description

Job Description

We are seeking an experienced Engineering Project Manager to oversee technical investment projects within a highly regulated biopharmaceutical manufacturing environment. This role offers the opportunity to manage engineering and validation initiatives.

As Project Manager, you take ownership of capital engineering projects from the initial concept stage through implementation and final transfer to operations. You work in a biotech firm and focus on entire project lifecycle of equipment, facilities and utilities. You supervise construction and validation activities, perform feasibility studies, monitor risk, and supervise multidisciplinary teams. You work closely with engineering specialists, operational teams, contractors, and leadership stakeholders. The position requires strong project leadership skills to manage schedules, risks, and technical requirements throughout the project lifecycle. You will be responsible for ensuring that all project activities align with industry regulations and internal standards.

Responsibilities

• Manage Capital Projects in a biopharmaceutical firm
• Lead projects focused on manufacturing equipment, facilities, and utility lifecycles
• Coordinate multidisciplinary teams to achieve project milestones and deliverables.
• Perform feasibility studies
• Continuous risk analysis, mitigation and improvement
• Create and present project updates to stakeholders and management

Requirements

• BSc or MSc, ideally in Engineering
• 5+ years of project management experience in a cGMP environment
• Experience with PM tools such as PMP, CAPM, or PRINCE2
• Knowledge of validation and qualification processes, including GAMP principles
• Experience with equipment lifecycle activities such as FAT, SAT, IQ, OQ, and PQ

Benefits

• Contract provided by Oxford, 12 month contract with possibility to extend
• Salary indication: €6500 - €7000,- gross monthly
• Full-time position, office hours. 4 days per week can be discussed
• Region: Amsterdam
• Vacaturenummer: 27646