Senior CQV Engineer

hace 2 días

Barcelona, Barcelona, España PM Group A tiempo completo
Overview

We have an opening for a Senior CQV Engineer

This person will be responsible for a variety of validation engineering related activities and for resolving project issues following cGMP regulations and Client standards. Leadership is an essential part of this role. The ability to motivate and mentor others in a dynamic, growing office environment is required.

Proven CQV leadership excellence experience in complex (life sciences/biopharma/pharmaceutical) facilities is required. 

This role is based in Basel, Switzerland.

Who we are

PM Group is an employee owned, international project delivery firm with a team of 3,600+ people.  We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations.  We are focused on growing a sustainable business centered on our people, our clients and trade partners.

Responsibilities

Serve as the Validation Engineering representative and technical subject matter expert (SME) on cross-functional teams; including but not limited to facilities, utilities and equipment.Responsible for developing validation strategy and coordinating validation activities required to complete small to large scale Client validation projects; including but not limited to equipment, utilities, and facilities.Lead the CQV of process equipment for large Pharmaceutical Projects through Basic Design, Detailed Design, Construction, and CQV phases for process equipment and supporting systems. Equipment includes Cell Culture, Purification equipment, Filling Systems, Media Formulation & Dispensing systems, Isolator systems, vial filling machines, Cryo-Bag filling machines, etc.Manage the validation deliverables of these Client projects ensuring new facilities, utilities, equipment and systems are implemented within predetermined schedules and project budgets, escalating any potential issues as necessary.Generate, review/approve and lead the development of a variety of validation lifecycle documentation e.g. Validation Plans, URS's, Qualification protocols and reports.Execute protocols, as required.Participate in activities related to validation including design, build, maintenance, and change control.Leads and participates in risk assessments of new and existing equipment and facilities, as required.Schedules, tracks and communicates project status, as well as project risks and recommendations to stakeholders.Collaborates with other team members and stakeholders to ensure goals and objectives are achieved.Mentor junior engineers; as required. Qualifications
  • Bachelors in Engineering and/or Science.
  • Valid Professional credentials Degree/Masters in Engineering and/or Science - preferred.
  • A minimum of 10 years' experience in CQV with at least 3 major capital projects completed.
  • Broad expertise in interdisciplinary coordination on projects, preferably in the biopharma sector.
  • Has functioned at a CQV Team Lead level at a scale of Pharmaceutical Projects.
  • Good time management and leadership skills.
  • Self-starter and decision-maker
  • Flexible and willing to travel locally to meet project requirements.
  • Have the ability to scope work and generate project proposals & cost estimates.
  • Have the ability to present to Clients, academics, students on CQV topics.
  • Have an excellent understanding of CQV execution methodologies for GMP pharmaceutical facilities.
  • Have the ability to deal with Senior Management constructively while defending the project's CQV scope, resources, etc.
  • Maintain and drive quality standards within the Department
  • Have good communication & people management skills
  • Have good client interaction skills
  • Strong knowledge of technical standards and regulations.
  • German language is required.

All of your information will be kept confidential according to EEO guidelines.


Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy.
 
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
 
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know. 

  • Senior CQV Engineer

    hace 3 días

    Barcelona, Barcelona, España PM Group A tiempo completo

    Overview We have an opening for a Senior CQV EngineerThis person will be responsible for a variety of validation engineering related activities and for resolving project issues following cGMP regulations and Client standards. Leadership is an essential part of this role. The ability to motivate and mentor others in a dynamic, growing office environment is...

  • CQV Lead

    hace 2 días

    Barcelona, Barcelona, España PM Group A tiempo completo

    Overview We are seeking an experienced Lead Commissioning & Qualification (CQV) Engineer to support a major pharmaceutical project based in the Basel region, one of Switzerland's leading Life Sciences hubs.. Responsibilities Lead a multidisciplinary team of technicians in delivering qualification, calibration, and automation I/O checks across all E&I...

  • Process Engineer – Equipment

    hace 4 días

    Barcelona, Barcelona, España Adryan A tiempo completo

    Job Title: Process Engineer – Equipment & CQV Support (mAb Manufacturing)Location. Barcelona, Spain (on-site / hybrid)Engagement Type: ContractDuration: 10 months with possibility of extensionRole OverviewAdryan is seeking aProcess Engineerto support a monoclonal antibody (mAb) program through the specification, procurement, installation, and qualification...

  • Senior Backend Engineer

    hace 2 semanas

    Barcelona, Barcelona, España Insight International (UK) Ltd A tiempo completo

    Role: Senior Backend Engineer (.Net)Location: Barcelona, SpainJob Type: ContractRole Summary:The Senior Backend Engineer will play a critical role in building the core services and APIs for the project. Working closely with the Lead Backend Engineer, this role will be responsible for writing high-quality code, developing robust data solutions, and...

  • Senior Python Engineer

    hace 5 días

    Barcelona, Barcelona, España psd group A tiempo completo

    Senior Python EngineerSummaryLocation:Barcelona (Hybrid)Day Rate:NegotiableDuration:12 MonthsAvailability:ASAPAbout the ClientMy client is the air transport industry's IT provider, delivering solutions for airlines, airports, aircraft, and governments. Their technology powers more seamless, safe, and sustainable air travel.They are looking to hire an...

  • Senior Process Engineer

    hace 7 días

    Barcelona, Barcelona, España PM Group A tiempo completo

    Overview Due to our on-going success securing large-scale projects, we are looking to hire a Senior Process Engineer.PM Group is as a leading international engineering, architecture, project, and construction management firm. With a widespread network of offices across Europe, Asia, and the US, and a diverse team of over 3,600 people . We specialize in...

  • Senior Systems Engineer

    hace 3 días

    Barcelona, Barcelona, España Indra A tiempo completo

    Ubicación:Barcelona, ESPerfil profesional: Defensa y SeguridadExperiencia requerida: Más de 2 años de experienciaModalidad del puesto: HíbridoSENIOR SYSTEMS ENGINEER. Barcelona, Híbrido.En Indra Group, protegemos lo que más importaLideramos el desarrollo de soluciones tecnológicas punteras que refuerzan la seguridad nacional e internacionalÚnete al...

  • Senior Software Engineer

    hace 3 días

    Barcelona, Barcelona, España Mews A tiempo completo

    Can you help us change the world?At Mews, FinTech goes beyond payments. Our Accounting teams build the systems that make financial data trustworthy, auditable and ready for real-world reporting. From ledgers to reconciliation, we power how hospitality businesses close their books with confidence. About the roleWe're looking for a Senior Software Engineer to...

  • Senior IT Infrastructure Engineer

    hace 2 días

    Barcelona, Barcelona, España Perk A tiempo completo

    Senior IT Infrastructure EngineerLocation:Barcelona (On-site, within commuting distance to the Barcelona hub)About the RoleTo ensure the continued growth and scalability of our business, particularly in the European region, we are addressing current gaps in our IT support structure. We are hiring a Senior IT Infrastructure Engineer in Barcelona to provide...

  • Senior Electrical Project Engineer

    hace 3 días

    Barcelona, Barcelona, España Vanderlande Industries A tiempo completo

    Job TitleSenior Electrical Project EngineerJob DescriptionPower up your career with us – we are looking for a talented Electrical Engineer ready to work on a variety of international projects involving technology and logistics solutions. The position of Electrical Engineer could well be the ideal next step in your career and personal developmentYour...