Why Patients Need You

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.

What You Will Achieve

You will be part of a multi-disciplinary team that provides training support for the cGMP clinical manufacturing (CM) of early phase drug product within Pharmaceutical Research & Development (PHRD).

The Training Specialist is responsible to provide training support to the drug product clinical manufacturing team 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.
• Ensures 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.

This role will reside primarily on-site in Andover, Massachusetts with some flexibility per management discretion.

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)) 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. 
  • This includes completing PCMs in support of SOP authors/SMEs
  • Acting as training point of contact to an SOP-determining training type and aligning SOP/training timelines.
• 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 current knowledge of regulatory requirements and cGMP expectations for training.  This includes awareness of those requirements for drug product 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 with aseptic behaviors.
• Maintain and archive training documentation as needed.

Qualifications

Must-Have

• Associates/BA/BS degree with minimally 2 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

Nice-to-Have

• 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, priority environment

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.

Other Job Details

• Last day to apply: November 15, 2024.
• Work Location Assignment: On Premise.

The annual base salary for this position ranges from $54,700.00 to $91,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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