Job Alert : CQV Lead

OUR CULTURE AND WORKING ENVIRONMENT

CoCEPTIO, pole of expertise trades & techniques active in very specific sectors (pharma, biotech, cosmetics, food-processing,?), has for ambition to become an inescapable European integrator in the conception and realization of industrial projects with high added value.

CoCEPTIO also wants to be attractive by the implementation of an agile management where trust, autonomy and responsibility are the key words so that our collaborators feel fulfilled and contribute spontaneously to the development of the company.

1. MAIN MISSION
2. Be CoCEPTIO’s referent on the approaches of qualification and validation on all the projects.
3. Remain up to date on the different evolutions

• OPERATIONAL RESPONSIBILITIES
• Be the lead of the Commissioning / Qualification / Validation cell
• In connection with the various customer’s internal stakeholders, and external (CQV providers, suppliers …):
• Take ownership of the project stages already completed (Conceptual, Basic, Detailed Engineering, Tender/Procurement)
• Define the best CQV strategy adapted to the projects, or optimize it
• Ensure the project management related to the CQV (scope management, budget-planning-quality control/reporting, risk management)
• Create, review, approve CQV project documentation
• Support the creation of the setup (organization, processes, technologies, documentation) necessary for the perennial customer support.
• Lead & coach the CQV team (internal or external)
• Work closely with QA for GMP inspections & approvals
• Work closely with the End-Users until the actual start-up of the units

• PROFILE AND KEY SKILLS

Qualifications:

• Master degree at least (or equivalent: industrial engineer, civil engineer…)
• At least 15 years of professional experience in the field: CQV + biotech (viral vectors/vaccines).
• Successful track record of involvement in complex CAPEX project environments (>> 30M€, cGMP, biotech, fast-track)
• Successful project experiences according to ASTM E2500-13 (strategy set-up and execution)
• Experiences in different contexts (clients, companies, project size)
• FR & EN

Required qualities:

• ● Leadership
• ● Excellent analytical and synthesis skills, anticipation
• ● Rigour, precision
• ● Constructive critical spirit, ability to innovate, “thinking outside the box” mindset
• ● High capacity for autonomy, prioritization of actions and objectives
• ● Ability to do operational tasks yourself, and/or to have them done and supervised
• ● Ability to work under very constrained environment (timing, budget, quality level, complexity)
• ● Initiative, pragmatism, constant solution orientation
• ● Positive & “ONETeam” spirit

Reporting, main interactions :

• PM client
• Customer project team (engineering/facility, procurement, QA, end-users, maintenance/metrology, IS/IT expert)
• Suppliers
• CQV provider(s)

Interested in a new career at CoCEPTIO?

Please contact Mr. Thierry Marchandisse, HR Manager at info@coceptio.be