GMP Manufacturing Training Specialist

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The GMP Manufacturing Training Specialist acts as a liaison with the Technical & GMP Training Department regarding training content, delivery and metrics and ensures that activities are appropriately tracked in the Learning Management System (LMS). The GMP Manufacturing Training Specialist role provides technical proficiency and consultative guidance as a business subject matter expert (SME) in the creation of On-The Job training materials in our cleanroom production areas. This position is a vital business partner who is passionate about training & committed to excellence while ensuring personnel are properly trained prior to performance. Collaborates with supported areas to ensure training plan objectives are met through effective learning and training solutions. The role is the Point of Contact for consulting on curriculum development for new or modified roles, and cross-assets training projects. The GMP Manufacturing Training Specialist is a role model in the organization, understanding and promoting GMP mindset and behaviors that drive a Quality Culture with our cleanroom production area.

Key Accountabilities and Duties:

  • Collaborates with Technical & GMP Training Business Partner and/or Technical & GMP Instructional Designer in developing training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience (e.g. videos, computer based training, wiki, websites, LQMs, trainee and trainer manuals, job aids, etc.) and any other general information intended to expedite on-boarding and development of personnel.

  • Coordinates and conducts dynamic and interactive GMP classroom and / or On-The Job training sessions on topics included in the Manufacturing On-Boarding topics. This will often be conducted directly in our cleanroom production areas "on the floor".

  • Acts as the Asset liaison with the Technical & GMP Training Department regarding training completion and training compliance metrics/KPIs and ensures that activities are appropriately tracked in the LMS. Collaborates in the development and adherence to Portsmouth site and Asset Annual GMP Training Plan.

  • Leverages knowledge of business and customers in order to identify SMEs and potential departmental trainers.

Qualifications/Skills:

  • B.A. or B.S. is strongly preferred. Preferred area of study in relevant STEM field or Education.

  • Prior biotech, pharmaceutical, or life science manufacturing background highly preferred. Does not necessarily have to be in a training capacity.

  • Prior experience working in a GMP/cGMP manufacturing environment is preferred.

  • Cleanroom or laboratory experience is preferred. Will consider candidates with training or teaching background in an academic setting, preferably at university/college level.

  • Strong /detailed knowledge and understanding of biopharmaceutical manufacturing process, related equipment and purpose and function of supporting processes is preferred.

  • Application of adult learning theories and training facilitation and delivery preferred.

  • Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.

  • Able to communicate status, needs, forecasts, risks and timelines effectively to management.

  • Displays a clear willingness to listen to others.

  • Has good interpersonal skills and works interdepartmentally in an effective manner to achieve objectives.

  • Shows commitment and dedication and strives to be ahead of schedule.

  • Practices safety awareness at all times and considers impact of actions prior to executing activities. Is passionate for training and to train others.

  • Must be computer literate and able to effectively use the full MS Office suite of applications.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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.

Reference: R42012