Engineering Training and Compliance Specialist

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Oct 19, 2021
Ref
4822592
Required Education
Bachelors Degree
Position Type
Full time
Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, the Training and Compliance Coordinator is primarily responsible for ensuring training and compliance within the Engineering Maintenance and Utilities group, including reviewing, evaluating, and working with the team to resolve potential compliance issues within the organization’s manufacturing facilities. The individual in this role will ensure that employees are adequately trained and systems are compliant with the rules and regulations of Pfizer as well as industry regulatory agencies. The Training and Compliance Coordinator will be responsible for monitoring, reporting, and aiding in remediating any compliance issues as well as tracking completion of compliance related commitments and manufacturing investigation reports. The Training and Compliance Coordinator will also be responsible for coordinating with Subject Matter Experts (SME’s) and other departments during site audits. The Training and Compliance Coordinator will also be responsible for reviewing current group training curricula’s, develop role specific modules to minimize unnecessary trainings and conducting training as needed. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Develop and conduct compliance reviews, assessments, analyses, and other business engagement activities within established frameworks to identify, track, and report on the remediation of compliance gaps
  • Create, maintain, and monitor compliance systems to ensure effectiveness in all manufacturing areas
  • Develop and prepare meaningful reporting and tracking of compliance activities to enable effective communication to senior management and all facilities
  • Assist in the ongoing development and enhancement of the compliance program
  • Keep current on emerging compliance issues and trends
  • Assist with and oversee compliance training needs in all departments and areas in Engineering.
  • Supervise the submission of responses to regulatory agencies
  • Develop and maintain relationships with quality organizations.
  • Create, maintain, improve, and track the Company’s standard operating procedures and policies in collaboration with Engineering
  • Lead investigation and resolution into compliance concerns
  • Create and manage effective action plans in response to audit discoveries and compliance violations.
  • Assess company operations to determine compliance risk.
  • Ensure all employees are educated on the latest regulations and processes

​​Qualifications

Must-Have

  • Bachelor's Degree
  • 5+ years of demonstrated experience in product development, manufacturing science and technology, within the pharmaceutical industry
  • Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control
  • The ideal candidate will be well organized, detailed oriented, and have strong problem-solving skills
  • work comfortably under pressure, and deliver on tight deadlines.
  • The Training and Compliance Coordinator should be confident, professional, and self-motivated with a keen interest in the ethical, legal, and regulatory requirements of a business.
  • Top candidates will have outstanding presentation and report writing skills, with the ability to work on their own initiative and as part of a team.
  • Ability to follow written procedures and monitor others for adherence to written procedures.
  • Ability to create or update written procedures with site operations personnel
  • Team player with strong interpersonal skills.
  • Open-minded self-starter with the ability to adapt and problem solve, as well manage multiple tasks concurrently.

Nice-to-Have
  • Master's degree

  • Relevant pharmaceutical experience

  • Demonstrated ability to train and coach others

  • Experience with Six Sigma or other operational excellence programs

  • In-depth knowledge of drug substance/drug substance intermediate manufacturing technology

PHYSICAL/MENTAL REQUIREMENTS

  • Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits, and hosting inspections, communicating one on one or with larger groups).  Ability to independently problem-solve and make recommendations for solutions. 
  • As this role can represent Pfizer potentially to third parties or BoH inspectors it is essential that the candidate can remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation.
  • Role is primarily office-sitting, standing, walking, and bending.  This is inclusive of leading/participating in Webex.
  • Perform complex data analysis for process analysis, troubleshooting or process improvement.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Standard M-F on-site work week, days.  No travel required.

Other Job Details:

  • Last Date to Apply for Job: 10/29/21

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Engineering

#LI-PFE