GMP Training Specialist 2

The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO

8d•$79,100 - $118,700•Onsite

About The Position

The cGMP Manufacturing Training Specialist 2 at our Cherokee site/3300 S. Second Ave, St Louis, will be expected to design, develop, facilitate and lead staff training programs and initiatives while fostering a collaborative learning culture. You will oversee the training performance and compliance within operations. You will be responsible for maintenance of the training curriculums within GMP Operations, in addition to continuous improvement of the training systems to ensure they remain consistent with current expectations for manufacturing staff. This position requires technical knowledge pertaining to GMP Manufacturing and associated quality regulations, training development and delivery, change management, and strong analytical skills. The cGMP Manufacturing Training Specialist 2 position is a key role within our GMP Operations Systems & Support team. Expectations of the GMP Operations System & Support team is to ensure “Compliance “and “Readiness” within our GMP Manufacturing teams, ultimately enabling high manufacturing success.

Requirements

Bachelor’s Degree in Chemistry, Biology or any scientific discipline
2+ years of experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT)
2+ years of experience in a training role
OR
High school diploma or GED
5+ years of experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT)
3+ years of experience in a training role

Nice To Haves

Experience working with Training systems to track and evaluate compliance management and program effectiveness
Strong interpersonal and communication skills and the ability to work effectively within a team environment
Strong knowledge of GMP API manufacturing
Detailed oriented with a future oriented mindset
Highly motivated self-starter who takes initiative and thinks creatively to develop innovative solutions.
Strong training and facilitation expertise, including designing, delivering, evaluating, and continuously improving training programs, curricula, and methodologies while fostering discussion, consensus, and positive change.
Proficiency with ManGo, TrackWise, and SAP systems, along with demonstrated process improvement experience and familiarity with FDA, EMA, and other applicable regulatory standards.
Prior training experience in an API manufacturing environment
Demonstrated knowledge and experience in various computer skills, including Windows (Word, Excel, PowerPoint, etc.)

Responsibilities

Train staff on GMP/GDP standards, safety and quality best practices, API and intermediate production techniques, and proper operation of manufacturing equipment and records.
Led comprehensive onboarding and delivered group and individual training for new Operations staff across a range of technical and operational areas.
Partner with Operations managers to design, execute, and administratively manage comprehensive training programs—including custom instructional materials and visual aids—aligned with core organizational goals.
Design robust GMP training programs by conducting targeted needs assessments across individuals, teams, and operations, leveraging post-training evaluation data to continuously refine instructional methods and learning objectives.
Create and track key performance indicators demonstrating successful training compliance
Identify and implement improvement projects that improve skillset of senior employees and subject matter experts
Lead Train the Trainer initiatives to expand training knowledge and ability of senior staff and subject matter experts
Serve as an Operations Training subject matter expert during customer audits and regulatory inspections
Work effectively cross-functionally by interacting daily with colleagues across the site
Complete/assist with deviations and CAPAs related to training program