Engineering Lead, Commissioning

6 maanden geleden

Leiden, Nederland Johnson & Johnson Voltijd

Johnson & Johnson is currently seeking an Engineer Commissioning & Qualification Lead to join our TEAM

MAM Engineering is recruiting a Lead to provide leadership to the C&Q team, ensuring compliance with all applicable regulatory, J&J Quality standards in the Engineering Projects. This person will play a role in our Engineering Leadership Team.

**Key Responsibilities**:

- Provide Leadership and direction to a team of Qualification Engineers to drive qualitative and balanced continuous improvement in the Engineering Team and project delivery excellence.
- Champion the adoption of Risk-Based Qualification projects and E2E C&Q Digital validation
- Ensure alignment with J&J standards along with engineering methodologies and standard processes.
- Support the C&Q team in any adjustments which may be required with the aim of crafting a robust, efficient C&Q strategy to suit the projects.
- Drive the team to effective and efficiently execute C&Q activities to deliver quality project outcomes meeting performance expectations.
- Lead project stage gate reviews for C&Q to ensure strategy is being implemented accurately and support issues as required.
- Be a key player in resourcing decisions and selection of technical solutions.
- Support the Leiden Site MAM Engineering Lead in ensuring short
- and long-term availability for C&Q resources.

**Qualifications**:

- Bachelor’s degree or equivalent degree in Engineering (Chemical, Mechanical, or Industrial) or other scientific field, required.

**Experience and Skills**:
**Required**:

- A minimum 10 years of relevant experience in similar roles.
- Experience with current commissioning and qualification methods, including ISPE, ICH, and Risk-Managed approach.
- Experience leading internal and external teams.
- Knowledge of local regulatory requirements for pharmaceutical and/or medical devices facilities
- Strong problem solving and troubleshooting skills.
- Knowledge of Digital Validation platform (e.g.,Kneat).
- We are looking for someone with a proven track record to coach professionals through solving difficult problems, and in delivering engineering projects.
- We seek someone who can influence with and without authority, prioritize a wide variety of projects and job responsibilities simultaneously, and implement work through your team members.

**What we offer**:
Janssen Biologics in Leiden, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Advance Therapeutic Medicinal Products. At Janssen Biologics, enthusiastic people are working together in a high-performance culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and contribute to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark

Your development is key to us, and we consider it our day-to-day responsibility. We believe we can make a difference together and take your career seriously. Through on-the-job and development trainings, assignment to projects and programs, we are committed to your personal and professional growth. Via multiple employee benefits, our company offers support for you and your family now and in the future.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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