Ingénieur; e de Projets C&Q - VSI - Data integr

Ekium Job Opportunity

Welcome to Ekium! With 2,500 talents in 15 countries and €300 million in revenue over 35 years, we are a dynamic team of enthusiastic engineers, experts, and technicians working together to bring industry closer to societal challenges.

We are involved in many specialized domains from industry to energy and the naval sector. Our strength lies in our employees, and we are committed to preserving their health and safety every day, as together we build a sustainable future.

Imagine yourself in the Ekium universe and discover the diversity of projects you could work on tomorrow:

• Write and execute qualification protocols (IQ, OQ, PQ)
• Coordinate the commissioning tests of equipment and systems
• Validate technical installations (HVAC, utilities, production equipment)
• Supervise performance and compliance tests
• Manage deviations and non-conformities detected during qualifications
• Write qualification reports and final summaries
• Ensure complete documentation traceability of C&Q activities

• Develop validation plans for automatized systems (VP)
• Perform risk analyses (AMDEC, risk matrix)
• Write user and functional specifications (URS, FS)
• Execute validation tests (Installation, Functional, Performance)
• Validate interfaces between systems (ERP, LIMS, MES, PLCs)
• Manage changes to validated systems (Change Control)
• Ensure periodic review and revalidation of systems

• Audit the conformity of practices to ALCOA+ principles (Attributable, Readable, Contemporary, Original, Accurate)
• Evaluate risks to data integrity in systems and processes
• Implement technical controls (audit trails, access rights, electronic signatures)
• Train users on good data integrity practices
• Write and update data integrity procedures
• Investigate incidents and deviations related to data integrity
• Prepare dossiers for regulatory inspections (FDA, EMA, ANSM)

• Plan and coordinate qualification/validation activities (planning, resources, budget)
• Lead project meetings with stakeholders (production, quality, IT, suppliers)
• Monitor progress and report to sponsors and management
• Manage project risks and implement corrective actions
• Coordinate interventions of contractors and suppliers
• Ensure compliance with deadlines, costs, and quality requirements

• Ensure compliance with GMP references (FDA 21 CFR Part 11, Annex 11 EU GMP, GAMP
  5)
• Maintain up-to-date quality documentation (SOPs, master plans, traceability matrices)
• Prepare for and participate in regulatory audits and inspections
• Perform regulatory and technological surveillance
• Archive and manage the documentary lifecycle

• Provide technical support to operational teams
• Identify and propose process and system improvements
• Participate in CAPA (Corrective and Preventive Actions)
• Contribute to the standardization of validation methods
• Participate in innovation and digital transformation projects

Profile:

• Graduated from an engineering school or equivalent university (Bac+5), with a specialization in chemical engineering, process engineering, or generalist with experience in process environments.
• Minimum of 2 years of experience in managing industrial projects in the chemical, fine chemical, or pharmaceutical sectors.
• Good command of project management tools (MS Project, Primavera, etc.).
• Organizational skills, leadership, team spirit, and result orientation will be your assets.

The Ekium environment:

Interest participation bonus, restaurant vouchers, annual vacation bonus, CSE benefits (holiday vouchers, gift cards, etc.)

A committed company:
Ekium is a signatory of the engineering charters for climate and diversity

Close management

Possible remote work depending on the task performed

A friendly environment adapted to people with disabilities

Colleagues passionate like you with a community of business and software references!

A collective vigilance that improves daily the quality and safety of our services

Opportunities for growth through an internal mobility charter

Belonging to the SNEF Group which has been growing for over 115 years