Why Patients Need You
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Cleaning Validation ensures that our manufacturing equipment and processes meet site requirements, which is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
The Cleaning Chemistry Scientist/Engineer will provide support and organize tasks related to the manufacturing plan of record within the realm of cleaning chemistry, equipment cleaning validation, and equipment changeover project management within a biopharmaceutical manufacturing facility.
This role will report to the cleaning validation program manager and provide support to both the cleaning validation execution team and the manufacturing equipment product changeover coordinator. The Cleaning Chemistry Scientist/Engineer will interact with manufacturing, quality, and engineering groups to ensure timely execution, review, and closure of cleaning validation activities in alignment with the site plan of record.
As a Cleaning Chemistry Scientist/Engineer, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your communication skills and your ability to collaborate with different departments within the organization will help to establish right-first-time execution of cleaning validation activities. It is your dedication and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
This position will provide support for the Cleaning Validation Program and Cleaning Validation projects at the Pfizer Andover site. Key responsibilities will include:
Working directly with the cleaning validation execution team to coordinate and support cleaning validation activities such as cleaning OQ, cleaning PQ, cleaning requalification, and clean hold studies.
Completing review and approval of cleaning validation execution packages and their associated cleaning validation summary reports.
Collaborating with Pfizer organizations to manage the product changeover planning and assumptions for manufacturing facility changes from one product manufacture to another.
Supporting the cleaning validation program and procedural changes that enhance safety, compliance, and overall operational efficiency.
Supporting implementation of corrective actions and process improvements to both the cleaning validation execution team and the manufacturing equipment product changeover coordinator.
Being accountable for the quality and robustness of the cleaning validation program and procedure design.
Performing work in accordance with both compliance and safety requirements established for the program.
Role will be expected to work Monday – Friday standard shift. Weekends or off hours may be required as needed.
The incumbent in this position will be responsible for supporting and implementing the established cleaning validation approach.Assisting with supporting the site’s successful adherence to the overall site Validation Master Plan, Validation SOP’s, and ensure that validation executions meet all applicable Pfizer quality and compliance standards and applicable regulatory standards.
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
Candidate must have experience working in a biopharmaceutical or pharmaceutical manufacturing facility.
Candidate must have relevant experience with cleaning validation of biopharmaceutical or pharmaceutical facility manufacturing equipment.
Candidate must be able to work across functional areas such as operations, engineering, validation, maintenance, and quality.
Candidate must have good verbal and written communication skills and be fluent in English.
Experience with the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), and enterprise document repositories
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some occasional weekend or second shift support if required.
Other Job Details:
Relocation assistance may be available based on business needs and/or eligibility.
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.
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.