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Senior Scientist, Validation Lead

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Closing date
May 15, 2022

View more

Discipline
Physical Sciences, Chemistry
Position Type
Full Time
Job Type
Senior Scientist
Organization Type
Pharma
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Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. In your role, you will join a team which is responsible for the establishing and implementation of the validation strategy for a given sector of validation (i.e. equipment, computer system validation, continued process verification, process, cleaning, etc.) to ensure that the validation execution and documentation is compliant with plant and corporate validation requirements and policies. More broadly, you will be joining a department which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.

How You Will Achieve It

  • Provide oversight and maintenance of the facility validation master plan ensuring equipment is properly validated/maintained for indented use (e.g. repair, move, upgrade)
  • Plan and coordinate the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols and Impact / Risk Assessments.
  • Work with Operations, Quality, Technical groups and other site/network groups as required assisting with establishing business and compliance requirements of equipment and processes.
  • Review and approve change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
  • Prepare material for and deliver validation training to junior validation engineers on validation topics , includ ing, training on guidance/best practices
  • Ensure integration of validation schedule in production schedule for implementation of validation activities
  • Manage routine Quality systems, such as change Control, deviations, documentation and investigations
  • Works with the operations, engineering and technology transfer teams to define priorities on validation of new equipment as well as process/compliance improvements on existing processes and equipment.


Qualifications

Must-Have

  • Bachelor's Degree
  • 10+ years of validation experience in a GMP pharmaceutical manufacturing environment
  • Excellent communication skill s and able to deliver effective presentations to a variety of audiences
  • Ability to build relationships with internal and external stakeholders to influence outcomes
  • High proficiency in Word, Excel and have demonstrated aptitude for computerized systems
  • Excellent communication skills and proven ability to collaborate across departments and organizations
  • Excellent organizational skills, ability to manage multiple priorities, projects, and day-to-day work with minimal supervision with high accuracy.


Nice-to-Have

  • Master's degree with 7+ years of experience or PhD with relevant experience
  • Knowledge of GMP regulations/ guidance (21 CFR Parts 11, 210 & 211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry
  • Background in problem solving, negotiations, data integrity principles and project management/support in a matrixed reporting environment
  • Good understanding of risk management methodologies, with a proven ability to apply to Bio-p harmaceutical operations.


PHYSICAL/MENTAL REQUIREMENTS
  • Must be able to climb flights of stairs and be standing for ~1-2 hours at a time
  • Must be able to lift up to 25lb
  • Must be able to complete gowning activities
  • Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This is M-F 1st shift position (7:30am - 4:00pm) however, selected candidate may be asked to support off shift hours (nights and weekends) as needed; non-routine.
  • This position requires the candidate to perform duties at the facility therefore there is limited ability to work remotely


Other Job Details:
  • Last Date to Apply: May 25, 2022
  • Eligible for Employee Referral Bonus
  • Eligible for Relocation Assistance


#LI-PFE

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.

Research and Development

#LI-PFE
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