Position Summary

The Technical Trainer is accountable for driving results in a fast-paced environment by preparing and teaching programs to help employees learn new skills and refresh previously acquired abilities. The Technical Trainer is an experienced learning and development professional with technical training and cGMP expertise in the pharmaceutical, biotech or life science industries. The Technical Trainer will assess training needs, teach hands on classes, and create new material to ensure the employees are ready to perform tasks associated with their position. The Technical Trainer has the ability to develop, implement, manage, and measure the effectiveness of technical training and development programs. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Creates technical training programs/content according to site/department requirements.
• Works with site management to conduct needs assessments and identify site-specific technical training needs.
• Provides training schedules and agendas.
• Determines course content and objectives.
• Coordinates with internal and external subject matter experts for content development and implementation.
• Prepares training materials and organizes training sessions for groups or individually.
• Conducts hands-on skills training for technical positions.
• Oversees technical training as part of the quality management system for assigned work groups within Alcami. This may include larger or multiple sites.
• Partners with Department Owners to ensure accurate and relevant assignment of curriculum in the Electronic Document Management System (EDMS) within Alcami.
• Oversees the train-the-trainer certification for assigned groups. Provides coaching to certified trainers.
• Creates reports of training completion status.
• Advocates timely completion of training and adherence to all regulatory compliance requirements.
• Supports and participates in quality, client and regulatory audits as required.
• Completes other project work as required to support changing business requirements and resourcing requirements.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

• Bachelor's degree in a life science, training and development or related field required or equivalent experience.
• 5+ years of relevant experience.
• 3+ years of technical training experience, including developing curriculum and writing course content.
• 3+ years of experience advising and influencing internal stakeholders (leadership, technical trainers, etc.)
• Prior pharmaceutical or CDMO industry experience required.
• Direct experience and working knowledge of aseptic techniques and supporting equipment, including but not limited to: Isolators, BSCs, Laminar Air Flow Hoods, and/or RABS preferred.
• Experience performing aseptic manipulations and interventions preferred.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and proactively engages in safety initiatives.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• Expert knowledge of cGMP and quality management systems.
• Strong knowledge of Federal Regulations, U.S. Food and Drug Administration (FDA), current Good Manufacturing Practices (cGMPs) and other applicable industry guidance documents.
• Extensive knowledge in aseptic gowning, aseptic manufacturing, and/or other aseptic techniques.
• Familiarity with cleanroom processes including Cleanroom cleaning and maintenance, logbook completion, and industry legislation and guidance documents.
• Expert knowledge of instructional design, blended learning and contemporary learning methodologies.
• General working knowledge of MS Word, PowerPoint, Excel, Outlook.
• Awareness of and ability to learn emerging learning technologies (LMS technologies, Adobe Flash, Captivate, etc.).
• Excellent written and verbal communication skills.
• Excellent attention to detail.
• Excellent training and facilitation skills.
• Excellent project management skills and ability to manage multiple priorities.
• Ability to manage, adapt to and influence change in a dynamic, high pressure environment.
• Ability to coach and influence internal key stakeholders.

Supervisory Responsibilities

• No direct reports, but accountable for leading and influencing others.
• Participates in the hiring process of other employees.
• Schedules and/or reviews the work of other employees.
• Coaches, mentors and develops other employees.

Decision Making and Supervision Required

• Uses professional concepts and company policies and SOPs to solve a variety of problems.
• Determines methods and procedures, including new assignments and the work of others.

Travel Requirements

• Up to 30%

Work Environment and Physical Demands

While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.