Senior Validation Engineering Technician

ROLE SUMMARY

Provide Engineering Tech support related to the qualification of manufacturing processes and equipment within a biopharmaceutical manufacturing facility, such as cleaning validation, cleaning monitoring, and cleaning change over. Additional validation responsibilities will also include but not limited to; chamber qualification, sterilization qualification, steam quality testing, and revalidation assessments.

Work includes generating validation/qualification documents and execution of qualification activities.

ROLE RESPONSIBILITIES

• Work with Operations, Quality, Technical groups, and other site/network groups as required establishing business and compliance requirements of the asset.
• Plan and coordinate the validation work assigned.
• Lead cleaning validation projects
• Technical understanding of process and equipment to be qualified
• Accountable for quality of work performed.
• Perform the work in accordance to all the compliance requirements and in a safe manner.
• Execute cleaning validation sampling, as required

BASIC QUALIFICATIONS

• HS Diploma or GED/Equivalent or prior Military experience required and have a minimum of five years working experience in a Biopharmaceutical or pharmaceutical manufacturing facility
• Hands-on experience is critical in this role of Validation Technician and selected candidates must be able to operate independently
• Candidate should understand cGMP systems and practices.
• Candidate must be able to work across functional areas such as operations, maintenance, quality and regulatory.
• Good verbal and written communication skills are required.
• Technical writing and document review skills are required.

PREFERRED QUALIFICATIONS

• Bachelor’s degree in relevant science field with minimum of 5 year of experience in a Biopharmaceutical or pharmaceutical manufacturing facility
• Candidates must have a solid understanding the Biopharma manufacturing process and operation of the equipment, such as the cleaning processes, SIP processes and autoclaves.
• Previous experience with cleaning validation
• Knowledge of site systems; EAMS, PDOCS
• Previous training experience

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 throughout site.
• Ability to manage competing priorities within a given work shift.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Monday – Friday first shift: 8:00AM – 4:30PM. This may vary according to the business need.

Eligible Employee Referral Program

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.