Pharmaceutical Operations Training Specialist

Responsibilities:

• Develop and implement standard operating procedures (SOPs) and best practices to enhance operational efficiency.

• Lead or facilitate on-the-job training (OJT) programs and studies to optimize workflow and process sequencing.

• Assess employee training needs and collaborate with operations to design and execute improvement plans and effective OJT programs.

• Recommend strategies to maximize equipment uptime and reduce downtime, ensuring optimal resource utilization.

• Demonstrated leadership abilities, including coaching, performance assessment, employee development, motivation, and empowerment.

• Proficient in change management, with a proven track record of challenging the status quo and driving continuous improvement initiatives.

• Lead by example through a strong work ethic and a hands-on management style.

• Thrive in both independent and team settings within fast-paced, deadline-driven environments, while effectively influencing peers and senior leadership.

• Highly self-motivated with strong attention to detail, adherence to deadlines, and proficiency in reporting.

• Contribute to and support Failure Mode and Effects Analysis (FMEA) for equipment and processes, identifying risks and reporting insights to cross-functional teams to guide training initiatives.

Qualifications:

• In-depth knowledge of GxP compliance in pharmaceutical manufacturing and regulatory standards, including EHS&S requirements.

• Hands-on experience in biotechnology production, aseptic processing (fill/finish), inspection, packaging operations, and process development.

• Comprehensive understanding of formulation and filling processes.

• Excellent communication and interpersonal skills, combined with a proactive and energetic approach.

• Familiarity with project management principles and control tools.

• Proficient in the use of data management systems and conducting FMEAs.

• Bachelor’s degree in Engineering or Life Sciences preferred.

• Over 5 years of relevant industry experience.