Shire Sr Technical Trainer, Mfg. in Los Angeles, California

This position reports to Swing (2) shift in B5. This shift schedule is Monday to Friday 2:24 PM to 10:18 PM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

Responsible for coordinating, scheduling, conducting and documenting Structured-On-The-Training (SOJT) and Instructor Led Training (ILT) from basic to highly complex learning activities. Participate in employee performance improvement initiatives and collaborate with Operations to increase effectiveness of job-specific GMP training. Collaborate with Subject Matter Experts (SME’s) within multiple process areas, to assist with SOJT support as needed. Lead training effectiveness improvement projects. Participate in new process and procedure project working and continuous improvement teams.

Essential Duties and Responsibilities

  • Collaborate with shift Supervisor to develop and implement training plan.

  • Coordinate, schedule and provide hands on training on core manufacturing tasks, SOP’s and equipment operation per training plan.

  • Conduct periodic audit sessions for employees evaluating compliance (including investigations), effectiveness of training, and comprehension of training.

  • Support development and execution of cross-training plans for assigned areas.

  • Coordinate and monitor training need.

  • Maintain and/or increase expertise in the areas in which incumbent is providing training.

  • Prepare, deliver and maintain innovative and instructive training materials for training program.

  • Deliver New Employee Orientation training sessions as needed

  • Respond in a timely manner on any follow-up issues or action items after a training session.

  • Facilitate learning by using a variety of active learning methods and adult learning concepts to develop participants’ competencies and to help learners meet specified performance expectations.

  • Will be required to trouble-shoot procedures and processes and incorporate compliance, training, and mistake-proofing improvements.

  • Evaluate, review and revise/or create SOP’s in accordance with periodic requirements or as needed.

  • Update and maintain training matrices and training plans to identify training gaps, track status and workforce levels.

  • Assign training role(s) within current Learning Management System (LMS) to employees based on current need or applicable changes in organization per training plan.

  • Ensure personnel training requirements are met and records are current per quality and regulatory requirements.

  • Create and implement training materials that supplement associated SOPs and processes for assigned areas.

  • Develop new, review, and/or revise performance evaluations, training standards, quizzes and proficiency standards as needed.

  • Review, update or create training roles for employees based on current practices or applicable changes in organization.

  • Work with core project teams and other training experts to plan and implement training strategies for new products or processes.

  • Demonstrate mastery of applicable process concepts, technical content, course curriculum and training methodologies.

  • Implement new training programs by conducting train-the-trainer sessions.

  • Lead training effectiveness and improvement activities to support area goal and objectives.

Qualifications

  • Knowledge of best manufacturing practices.

  • The incumbent must work in a clean room environment wearing special garments.Additionally, personal protective equipment must be worn due to safety requirements.

  • (Preference) In depth manufacturing process knowledge, including proficient knowledge and qualification in one or more processes, intermediate suspension, centrifuge operation, chromatography, COP, CIP, filtration, UF/DF, filter press operation and facility/equipment cleaning.

  • Expected to follow Good Manufacturing Practices and Good Documentation Practices (GDP) at all times.

  • An independent thinker, highly motivated individual with great communication and patience to train effectively for the purpose of having trainees perform tasks in a standard and compliant manner each and every time

  • Must demonstrate the ability to teach using adult learning techniques on assigned areas of knowledge.This may include the technical aspects surrounding theory and application.

  • Ability to manage multiple tasks concurrently and drive tasks to completion in a timely manner.

  • Solid organizational skills and ability to plan and suggest resolutions to technical or resource problems.

  • Computer literate and proficient of word processing and spreadsheets (such as Microsoft Office).

  • Must be very detail-oriented, conscientious, and responsible.

  • Strong interpersonal communication and influencing skills.Must have good verbal and written communication skills.Must have effective presentation skills.

  • Working knowledge of applicable SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs.Familiarity with cGMP audit process, exception management, quality systems, and interpretation of regulations.

  • Must be able to learn new computer systems and programs in a timely manner.

  • Must demonstrate proactive behavior.

Education and/or experience

Requires minimum high school diploma or GED. 4+ years of related work experience or AA degree or higher and 2+ years related work experience.

Physical Demands

• Must be able to lift, push, pull and carry up to 50lbs.

• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

• Will work in a cold, wet environment

• Must be able to work multiple shifts, including weekends.

• Must be able to work overtime as required. (only for non-exempt positions)

• May be required to work in a confined area.

• Some Clean Room and cool/hot storage conditions.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.