ROLE SUMMARY

The successful candidate will assume professional responsibilities within the API (Active Pharmaceutical Ingredient) compliance group. Primary responsibilities include managing all cleaning and process validation activities for their assigned manufacturing areas. In addition, the candidate must interface regularly with customer and regulatory auditors and take a lead role in evolving compliance programs with the API area and across the corporation.

Key responsibilities include:

• Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.

• Support 24/7 plant operations with timely responses to complex validation concerns or cleaning failures

• Defend the validation programs and strategies to customer and regulatory auditors.

• Support API wide compliance initiatives.

• Support corporate compliance initiatives.

• Participate in and generate Quality Risk Management documentation.

• Train and mentor colleagues in cleaning/process validation tasks.

Qualifications

Must-Have

• 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.

• Work experience must include API manufacturing and/or cleaning/process validation.

• Experience in collaborative working and problem-solving is essential

• Understanding of regulatory standard and guidance documents as well as evolving cGMPS impact pharmaceutical production

• Strong technical, analytical and problem solving skills with ability to make timely decisions

• Change Agile, with willingness to learn and be challenged

• Physical Demands: Frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access.

• Work Environment: Office environment, with frequent time in the manufacturing. Use of hearing and eye protection is required.

• Technical Writing: Demonstrated ability to write effectively with emphasis on technical content.

• Role supports a 24 hour production environment. Primary responsibilities occur M-F during normal working hours. Some off hour and holiday coverage may be required. Must be available to support 24/7 – 365 operation.

Nice-to-Have

• Prior experience with eQMS, gQTS, PDOCS, gLIMS, CoreLIMS, and SAP.

PHYSICAL/MENTAL REQUIREMENTS

• Physical Demands:  Frequent time in both manufacturing and office environments.   The manufacturing environment includes equipment with moving parts.  Must be able to perform gowning requirements for entry in the manufacturing areas.

Requires lifting, sitting, standing, walking, stair climbing and roof access.  Must be available to support 24/7 – 365 operation. 

• Work Environment:  Office environment, with frequent time in the manufacturing areas.  Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.  Use of hearing and eye protection is required. 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Role supports a 24 hour production environment.  Primary responsibilities occur M-F during normal working hours.  Some off hour and holiday coverage may be required. Must be available to support 24/7 – 365 operation.

Relocation support available

Work Location Assignment: On Premise

Other Job Details:

• Eligible for Relocation Package

• Eligible for Employee Referral Bonus

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.

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.

Manufacturing