12 sep
|
Klinea Biotech & Pharma Engineering
|
Gerona
12 sep
Klinea Biotech & Pharma Engineering
Gerona
Klinea is seeking an experienced Senior Capital Project Manager to lead the final execution and operational transition of a major investment project within a regulated life sciences manufacturing environment.
The project is currently approaching the final stages of construction and it is entering a phase in which progressively, the facilities, systems and future operations, needs to be transfer to the site
The successful candidate will take overall responsibility for coordinating project completion, commissioning, qualification, start-up and handover. A key part of the role will be to connect the project organisation with the local site functions, align all stakeholders and ensure effective operational readiness.
Key Responsibilities ?
Project Leadership
- Lead the project through construction completion, commissioning, qualification, start-up and operational handover.
- Ensure alignment between scope, schedule, budget, quality requirements and business objectives.
- Coordinate engineering companies, contractors, equipment suppliers and specialist consultants.
- Oversee project controls, including cost, scheduling, risks, changes, outstanding actions and performance reporting.
- Support contract administration and the resolution of technical, contractual and organisational issues.
- Monitor progress, identify deviations and implement appropriate corrective actions.
- Ensure compliance with applicable GMP, quality, environmental and health and safety requirements.
- Report project status, risks and key decisions to site leadership and project governance bodies.
Operational Readiness and Handover
- Develop and lead an integrated operational readiness and transition plan.
- Act as the main interface between the corporate project organization, construction suppliers and the local site team.
- Mobilise and align all relevant departments, including Operations, Engineering and Maintenance, Quality, Validation, EHS, Automation, IT and Supply Chain.
- Establish clear governance, responsibilities and decision-making processes for the transition.
- Ensure that ownership of facilities, systems and outstanding actions is formally assigned to the appropriate site functions.
- Promote active involvement and accountability from the future owners and users of the installations.
- Coordinate the transfer of technical knowledge, project documentation and responsibilities to the site organisation.
- Oversee construction completion, punch-list closure, commissioning status, qualification readiness and resolution of outstanding technical issues.
- Ensure readiness of procedures, training, maintenance plans, spare parts, calibration activities, asset registration and technical documentation.
- Lead cross-functional readiness reviews to identify gaps, agree priorities and monitor action closure.
- Support start-up and ramp-up to ensure a safe, compliant and controlled transition into routine operations.
- Ensure that project closure includes a complete and formally accepted handover to the relevant site functions.
Candidate Profile ?
Essential Requirements
- Degree in Engineering, Construction Management or another relevant technical discipline.
- Approximately 10 years or more of experience in industrial capital projects.
- At least five years of experience leading capital projects or significant project packages.
- Experience managing investments of approximately EUR 30–100 million, or complex project packages exceeding EUR 15 million.
- Previous experience in the pharmaceutical, biotechnology, life sciences or another highly regulated manufacturing environment.
- Good understanding of GMP requirements and their impact on project execution, commissioning and qualification.
- Experience transitioning projects from construction and commissioning into operational ownership and routine manufacturing.
- Practical knowledge of operational readiness, systems handover, start-up and project close-out.
- Experience working either within an owner’s organisation or for an engineering, EPCM, construction management or consulting company in a client-facing leadership role.
- Strong knowledge in at least one of the following areas and solid working knowledge of another:
Project cost management
Planning and scheduling
Engineering and design management
Project management
Contract and contractor management
Construction management
- Ability to coordinate multidisciplinary teams and mobilise stakeholders without necessarily having direct hierarchical authority.
- Strong communication, leadership, negotiation and stakeholder-management skills.
- Professional working proficiency in English.
- Availability to maintain a regular and substantial presence at the site.
Desirable Requirements ?
- Previous experience in an FDA-regulated manufacturing environment.
- Experience leading an operational readiness, facility handover or manufacturing start-up programme.
- Experience working with international or geographically dispersed project teams.
- Knowledge of capital investment approval and project governance processes.
- Relevant project management certification, such as PMP or equivalent.
Working Arrangements
The position requires a strong on-site presence to coordinate effectively with the project team, contractors and plant stakeholders. An arrangement of approximately four days per week on site may be considered, depending on project needs and the candidate’s location.
Candidates may be based locally, relocate temporarily or commute weekly to Girona Greater. Travel and accommodation arrangements, where applicable, will be agreed as part of the engagement conditions.
Duration: Approximately 12 months
Start date: Immediate
Commitment: Full time
Working arrangement: Predominantly site-based
📌 Senior Project Manager - Klinea Biotech & Pharma Engineering (Gerona)
🏢 Klinea Biotech & Pharma Engineering
📍 Gerona