Use Your Power for Purpose
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them. Your contributions will be vital in achieving project tasks and goals, fostering a collaborative team environment, and enabling Pfizer to reach new milestones and provide aid to patients worldwide.
What You Will Achieve
You will be part of a multi-disciplinary team that provides training support for the cGMP clinical manufacturing (CM) drug product within Pharmaceutical Research & Development (PHRD).
The Training Specialist is responsible to provide training support to the drug product clinical manufacturing team and it’s support functions at the Andover, Massachusetts Pfizer Location. This will include the development, delivery, assessment, and maintenance of training program documentation (Read and Understand (R&U) Read and Test (R&T) and On the Job Training (OJT)) and courses within the Learning Management System (LMS). The individual is also responsible for coordination of standard operating procedures (SOPs) within the team.
Responsible for ensuring high quality and efficient learning in support of aseptic manufacturing operations and supporting functions.
Collaborate with the manufacturing operations team and supporting functions to effectively design, develop, implement and coordinate aseptic learning programs in support of business goals and site practices.
Ensure with respective management that all colleagues and contingent workers are qualified to perform their GMP responsibilities by efficiently managing the training curriculum in the LMS.
How You Will Achieve It
Development new and revise existing training program documentation (e.g. Read and Understand (R&U) Read and Test (R&T) and On the Job Training (OJT) and e-learning) collaborating with subject matter experts.
Create and deliver On-The-Job (OJT) training and Instructor-Lead-Training to operators and supporting functions as needed.
Coordinate with area management to create curriculum and deliver timely training to new hires.
Provide compliance oversight to procedural change management (PCM) documentation in support of SOP authoring.
Acting as training point of contact to an SOP-determining training type and aligning SOP/training timelines.
This includes completing PCMs in support of SOP authors/SMEs.
Act as PHRD CM TPOC with Pharmaceutical Sciences Training and Operations Quality Teams within Pfizer.
Ensure all necessary pre-requisite trainings are in place for all personnel.
Ensure that the training materials that require periodic retraining/requalification are managed effectively (e.g. aseptic gowning).
Communicate effectively, this includes communicating time sensitive training prior to task execution to PHRD Clinical Manufacturing Team as well as presenting training updates/metrics at weekly staff meetings.
Maintain understanding of regulatory requirements and cGMP expectations for training within Pfizer. This includes awareness of those requirements for drug product sterile operations and PHRD CM supporting functions to ensure training is aligned with current regulations.
Collaborate with Investigators when there is a human performance error learning category to drill down to root cause and apply effective CAPA associated as it relates to training.
Maintain and archive training documentation as needed.
Here Is What You Need (Minimum Requirements)
BA/BS degree with 0+ years of experience in Biotechnology Industry
Excellent communication skills, ability to actively listen, learn, translate concepts into training materials
Proficient in Microsoft applications or other electronic tools in support of training material creation
Have a basic understanding of GMPs and various types of training documentation (e.g. SOPs, User Guides, OJTs, training curricula)
Demonstrated practical application of theory, with enough credibility in day-to-day aseptic practice to be able to influence appropriate aseptic behaviors
Have clear track record of effective teamwork, collaboration and communication, with demonstrated ability to work in a cross-functional team environment
Strong organizational and prioritization skills to handle multiple tasks independently
Bonus Points If You Have (Preferred Requirements)
Basic understanding or experience in sterile drug product manufacturing. Demonstrated aseptic behaviors and techniques adhering to sterile regulations
Train the Trainer Certified with prior experience conducting OJT training
Demonstrated presentation skills to audience at various levels, with good written and verbal communication skills
Strong critical thinking and analytical skills with high attention to detail
Ability to manage change and deal with ambiguity
PHYSICAL/MENTAL REQUIREMENTS
Ability to spend time in the manufacturing environment (Standing and walking) training colleagues.
Ability to gown to enter non-aseptic and aseptic areas of the Liquid Dose Manufacturing Facility.
Collaborative skills and effective partnering skills in complex working environments
Ability to work independently and multi-task in a fast-paced environment. This includes demonstrating change-agility, specifically adjusting to business and compliance priorities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Standard Monday-Friday work schedule.
Ability to train operating colleagues that may work outside of standard business hours(shift) on occasion.
Ability to travel up to 5% to other sites, conferences and other events would be normal and expected.
Adherence to all site and department safety guidelines applicable to role.
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Manufacturing