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Manager Engineering Validation at Lonza Biologics Inc.

Posted in Architecture 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Hayward, California





Job Description:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

 

Job Description Summary

This position manages successful completion of Validation projects within boundaries of quality, time and budget supporting product manufacturing efforts for the site. Based on technical expertise, reviews and approves validation protocols. Manages and provides technical direction to reporting disciplined engineering validation staff members and external contracted validation resources.  Display an understanding of theories/practices of a variety of engineering validation principles and requirements.

Key Accountabilities and Duties:


  • Management, development and execution of site required validation objectives.

  • Management and execution of site Validation Master Plan.

  • Manages, identify, hires, develops and recognizes validation staff both reporting and contracted.
    Provides technical direction as required. Responsible for policy setting and defining procedures for the
    staff in accomplishing and documenting projects. Provides input on overall engineering department policy.

  • Financial responsibility for both validation departmental and capital expenses.

  • Reviews and approves validation feasibility of design concepts and analysis of technologies that incorporate area of experience.

  • Reviews and analyzes validation proposals, protocols and

technical report to determine if benefits derived meets GMP validation ,

requirements


  • Develops and recommends validation approaches for strategy concurrence, consideration and allocation of personnel and funds. Responsible for preparation of validation cost and resource estimates for site projects.

  • Monitors and manages OpEx expense and validation costs.

  • Responsible through subordinates for defining and managing validation scope of work.

  • Manages, identify, hires, develops and recognizes validation staff both reporting and contracted.

  • Provides technical direction as required. Responsible for policy setting and defining procedures for the staff in accomplishing and documenting projects.

  • Provides input on overall engineering validation department policy.

  • Approves protocols, reports, support documentation (Commissioning, IOQ, PQ, PPQ protocols to secure project release, execution and closure.

  • Manages a variety of complex issues in associated departmental Validation projects, provides guidance, direction to plans and schedules for project implementation.

  • Applies statistical analysis and design of approaches to process development validation activities.

  • Proactively communicates directly and regularly with site Quality Engineering, site functions ensuring local consistency for Validation Engineering methods, initiatives.

  • Perform other duties as assigned. 

 

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

 

Lonza.  The place to Go, Stay and Grow.