C&q Lead

vor 2 Wochen

Lausanne, Schweiz ALTOGEN AG Vollzeit

**ALTOGEN** is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.

With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.

We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.

**About the job**:
**To strengthen our team in Switzerland**, we are looking for a **Commissioning & Qualification Lead** (f/m/x).

C&Q Lead will provide oversight of the site commissioning and qualification organization in support of capital projects. The incumbent in this role will lead and manage an experienced team of colleagues and contractors focused on commissioning and qualifying facilities, utilities, OSD process equipment and Computerized System.
- The individual oversees the project C&Q work activities of major complexity to ensure on time and within budget completion.
- Responsible for driving the commissioning and qualification activities of a new facility (incl. Utilities, equipment, CSV,...)
- Lead a team of colleagues and contractors to achieve C&Q objectives aligned with capital project milestones and site goals.
- Approval the C&Q Firm deliverables.
- Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
- Design and author the validation/qualification approach (plan), provide the scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports.
- Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing.
- Lead/Support the implementation of structures, tools, and processes to actively manage C&Q activities.
- Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation

**About you**:

- Degree in Engineering or Science related discipline performed
- Minimum of 10 years of relevant pharmaceutical industry experience
- Minimum 10 years ‘experience in managing personnel and/or complex projects, including direct experience in managing different Commissioning/Qualification/Validation contractors and activities for large and complex projects.
- Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
- Excellent command of English and preferably French language.
- Project and change management experience. Experience with Product Life Cycle Management.

**What we offer**:

- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirt and an integration within the "Tribe"

Type d'emploi : Temps plein, CDI

Programmation:

- Du Lundi au Vendredi

Lieu du poste : Un seul lieu de travail

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