Job Descriptions

Job Specification:

• Project Planning and Execution: Lead the end-to-end planning, execution, and monitoring of large-scale capital projects within a GMP pharma operational setting. Develop detailed project plans, define scope, objectives, deliverables, and resource requirements. Ensure alignment with organizational goals and compliance with GMP guidelines.
• Budget and Resource Management: Develop project budgets, track expenses, and manage project resources efficiently. Identify potential risks and implement mitigation strategies to ensure projects are delivered within budget constraints.
• Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including engineering, operations, quality assurance, regulatory affairs, and other relevant departments. Foster effective communication, manage stakeholder expectations, and maintain strong working relationships to ensure seamless project execution.
• Technical compliance: Manage project utility and equipment installation, commissioning, and qualification. Experienced with new equipment installations as well as process optimisation projects. Resolve technical issues in an effective & timely manner to support operations. Ensure equipment/systems meet the required legal and corporate standards.
• Risk Management: Identify project risks and proactively develop strategies to manage and mitigate potential issues. Regularly assess project progress, identify deviations from the plan, and implement corrective actions as needed.
• Timelines and Milestones: Develop and manage project schedule/ Gannt , milestones, and timelines. Continuously monitor progress, anticipate delays, and adjust plans to ensure on-time delivery of project objectives.
• Quality Assurance: Ensure that all project activities align with the highest quality standards and GMP guidelines. Oversee the implementation of quality control processes, validation procedures, and documentation requirements.
• Environmental, Health & Safety: Ensure that all projects are delivered in accordance with the approved EHS plan. Maintain a safe and inclusive working environment while “leading from the front” across all safety matters.
• Reporting and Documentation: Prepare and present regular project status reports, updates, and performance metrics to stakeholders and senior management. Maintain accurate project documentation, including project plans, reports, change orders, and other relevant records.
• Change control: Co-ordinate all change control within the project. Utilise existing operational systems to identify and track all change. Ensure all change has been reviewed and is approved to proceed. Maintain a change control log for all projects under management.
• Commercial management: Ensure budgets are adhered to and reported on. Support commercial teams with scoping and negotiating new contracts. Raise purchase orders and issue to supply chain.

Qualifications and Requirements:

• Bachelor's degree in Engineering, Project Management, construction management or related field.
• Minimum of 8 years of relevant project management experience in the pharmaceutical or biotechnology industry, with a strong focus on GMP operational environments.
• Proven track record of successfully delivering large capital projects (€10m) on time and within budget.
• In-depth understanding of GMP regulations, quality standards, and regulatory requirements.
• Project Management Professional (PMP) certification is a plus.
• Excellent leadership, communication, and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Proficiency in project management tools and software.
• Ability to work in a fast-paced, dynamic, and changing environment.
• Exceptional organizational skills and attention to detail.

Skills

• Project management
• Leadership Skills

Experience

• 8+ years