Site Readiness Lead

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The Site Readiness Lead is responsible for planning coordinating and delivering all activities required to make the site ready for the increased volumes of key products and coordinates the capital investments site assessments in terms of solvent & waste management weighing & logistics capacity and general facilities to accommodate acceleration of volumes. The Site Readiness Lead is also responsible for building and executing the workforce planning in order to assure operational readiness by 2028.

Key responsibilities

• Lead site readiness planning for new processes equipment upgrades and production campaigns producing and maintaining integrated readiness plans checklists and timelines.

• Coordinate with Project Engineering Process Engineering QA EHS Maintenance Supply Chain and Operations to ensure alignment on commissioning FAT/SAT start-up and handover activities.

• Coordinates increased requirements on solvent and waste management including a E2E readiness plan on solvent circularity and availability for key products

• Coordinates increased requirements for Weighing & Logistics Storage and staging areas Mobile Equipments Central ME cleaning area and logistical flows onsite.

• Coordinates increased facility requirements such as offices parking cantine space ...

• Workforce planning and execution: onboarding training and competency assessments create training plans coordinate training delivery and verify readiness of operators and support staff.

• Acts as a primary liaison for the Geel site to the Global Network Strategy team.

• Develop review and approve SOPs work instructions risk assessments and operating procedures required for safe and compliant operation of new/modified equipment and processes.

• Coordinate and participate in process safety and risk reviews (PHA HAZOP Swift PHR GGA) and ensure identified actions are closed prior to start-up.

• Manage readiness-related testing pilot runs and introductory batches; analyze results and support corrective actions or process optimization.

• Act as the primary point of contact for technical and operational readiness issues; escalate and resolve cross-functional impediments to maintain schedule.

• Ensure full traceability and GMP-compliant documentation of all readiness activities deviations investigations and change controls.

• Drive continuous improvement by capturing lessons learned implementing preventive actions and supporting improvement projects.

• Provide clear status reporting to project and operations leadership (readiness dashboard risk register KPIs).

Required qualifications and experience

• Bachelors degree in Chemical Engineering Process Engineering Chemistry or equivalent by experience.

• Minimum 10 years experience in operations engineering or process engineering in a chemical or pharmaceutical manufacturing environment.

• Demonstrated experience leading commissioning qualification validation and operator training for new equipment/processes; involvement in project work of 10M or more is an advantage.

• Strong knowledge of cGMP quality systems and regulatory expectations for pharmaceutical/chemical manufacturing.

• Practical knowledge of production equipment (reactors centrifuges filters dryers) utilities and automation/control systems.

• Familiarity with MES SAP and distributed control systems (e.g. Delta-V PCS7) and laboratory systems (PAT NIRPRO) preferred.

• Experience with process safety tools and methodologies (PHA HAZOP root cause analysis 5 Whys).

Skills and competencies

• Proven leadership and stakeholder management skills; able to coordinate cross-functional teams and influence without direct authority.

• Excellent planning organizational and project management skills; able to manage multiple streams and deadlines.

• Strong verbal and written communication skills in Dutch and English.

• Analytical and problem-solving mindset; able to drive investigations and implement corrective actions.

• Attention to detail and strong documentation discipline aligned with GMP.

• Able to work in a hands-on production environment and lead by example in safety and housekeeping.

Key performance indicators

• Percentage of readiness milestones completed on schedule.

• Number and severity of safety incidents during commissioning/start-up (target: zero).

• Operational workforce readiness and competency pass rates prior to start-up.

• Time to achieve stable production post-handover.

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