Senior Cleaning Chemistry Scientist

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Job description

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 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 Senior Cleaning Chemistry Scientist will provide technical support and leadership related to the manufacturing plan of record within the realm of cleaning chemistry, equipment cleaning validation, equipment changeover project management, and process improvements within a biopharmaceutical manufacturing facility.

This role will provide technical support for the overall cleaning validation program, including the assessment of changes and their potential impact to cleaning validation, manufacturing investigation assessment, and project management of cleaning validation programs, including manufacturing equipment product changeover.

As a Senior Cleaning Chemistry Scientist, 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 innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

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 program manager to develop, implement, and monitor the strategy and philosophy in the area of cleaning chemistry and equipment product changeover.

• Supporting the design, troubleshooting and qualification of biopharmaceutical manufacturing equipment in the realm of the cleaning validation program.

• Drafting study plans and protocols in accordance with defined proprietary site strategies

• Overseeing and contributing to hands-on laboratory studies related to cleaning chemistry and documenting execution of studies to GMP standards.

• Supporting and participating in engineering studies in GMP environments, analyzing study results, and drafting study summary reports as needed.

• 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.

• Providing a technical understanding of processes and equipment to be qualified.

• Providing technical support and participating in the implementation of change controls and commitment action items.

• Providing technical support and supporting ongoing investigations.

• Being accountable for quality of work performed.

• Being accountable for the quality and robustness of the cleaning validation program and procedure design.

• Performing the work in accordance to all of the compliance requirements and in a safe manner.

• Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.

• Representing the cleaning validation program to regulatory inspectors and providing general audit support when needed.

• 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.

Qualifications

Must-Have

• Bachelor's Degree/Masters Degree in Engineering, Biology, or a Related Science (BS 8+ years experience / MS 4+ years experience), or equivalent experience.

• Candidate must have experience working in a biopharmaceutical or pharmaceutical manufacturing facility and have well developed hands on laboratory skills.

• Candidate must be able to work across functional areas such as operations, engineering, validation, maintenance, quality and regulatory.

• Candidate must have good verbal and written communication skills as well as strong technical writing skills and proficiency in experimental design.

• Experience in the area of validation activities supporting manufacturing and/or development, operating in regulated environment

• Experience with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15)

• Ability to work on own initiative

• Excellent communication skills and fluency in English

Nice-to-Have

• 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.

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.

Quality Assurance and Control

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