Capital Project Engineer (Contract) – Process Equipment & Utilities Projects

Capital Project Engineer (Contract) - Process Equipment & Utilities Projects Project Engineer/Manager role with background in delivering end-to-end projects in pharmaceutical Solid Oral Dose drug product manufacturing applications Leads and executes medium and large sized capital projects according to requirements for project management fulfilling all capital, quality, and compliance requirements. Area of projects implementation: Pharmaceutical processing equipment and associated utilities. Responsibilities:

• Uses project management methodologies and skills to manage capital projects of varying complexity across organizational boundaries and is responsible for their successful delivery.
• Ensure projects are conducted at the highest quality, within time and budget, and that the risk level is managed per procedures and stakeholder expectations.
• Coordinate and supervise project execution related activities through the full lifecycle, from initiation to close out (hand-over).
• Lead a cross functional team of internal and external specialists.
• Responsible for meeting project scope requirements, schedule requirements, and costs.
• Ensure compatibility and consistency with existing organization and industry standards (PMM, cGMP, GEP, etc.)
• Coordinates all stakeholders, facilitates problem solving sessions and/or other planning sessions, and makes adjustments in project in alignment with overall business strategy.
• Responsible for the adequate utilization of all quality systems as defined by Procedures within the projects organization.
• Ensures appropriate safety measures are taken to prevent injuries and minimize safety risks. Takes a proactive approach to safety.
• Ensures readiness for inspections together with quality organizations.
• Ensures compliance with rules and regulations of procurement and accounting

Technical/Functional Expertise

• Specific projects to be executed are generally in the Processing area of the site and include:
• Upgrade to high speed Capsule Filling equipment to accommodate granule handling
• New product introductions (NPI) in the drug product environment
• Upgrades to process equipment utilities & associated plant
• Replacement of fixed IBC lifting equipment
• Knowledge of manufacturing processes and engineering documents, such as equipment layouts, P&IDs, equipment supplier design documentation.
• High experience of executing full project lifecycle from conception through to handover & training
• Concept & Basic Design
• Capex applications
• Procurement
• Budget / Schedule / Scope management
• Management of supplier interface / detail design
• Management of EHS inputs
• Equipment installation, management of CQV
• Handover to end user & training
• Knowledgeable in project management methodologies.
• Awareness of current state of the art in the field of pharmaceutical engineering and familiarity with GMP and other regulations. Qualifications:
  • Bachelor's degree in engineering, science or other technical field (engineering degree preferred)
  • Minimum 10 years experience in running/managing projects/programs through full lifecycle with total costs up to €3M
  • Experience in a large company environment
  • Experience in working and communicating globally
  • Experience in pharmaceutical or biotech industry
  • Hands on attitude. Role will involve installation activities on the shop floor
  • Management of contractors & suppliers for site works
  • Strong financial and business accumen
  • High leadership skillset
  • High strategic thinking
  • High facilitation and presentation skillset
  • High stakeholder management skillset
  • Knowledge of scheduling and cost estimation/controlling
  • Anticipates and resolves conflict situations
  • Capability of analyzing and solving complex problems through innovative thought and experience
  • Team based player
  • High Quality & EHS awareness
  • Risk focused
  • Certified PM according by IPMA or PMI is a plus