Senior CQV Engineer

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, if 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.