Associate API Specialist Manufacturing

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Sep 28, 2021
Ref
4825190
Required Education
Bachelors Degree
Position Type
Full time
Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
 

What You Will Achieve

Your expertise will be employed analyzing and designing sequences of operations and work flow to improve the company's production facilities and validation documentation within regulations and GMP guidelines. Activities may include process monitoring, safety and environmental improvements, troubleshooting, process reliability improvements, cleaning and process validation, and technology transfers.  May establish or assist in establishing accident prevention measures and may train personnel concerning all phases of production operations, cleaning and process validation. Conducts studies pertaining to cost control, cost reduction, inventory control, production record systems, and cleaning and validation systems. On the basis of these studies, develops and implements plans and programs for facility modifications and revisions to operating methods. May assist project managers or engineers in the planning and design of facilities, equipment cleaning, and process change qualification/validation.  The candidate will interface periodically with customer and regulatory auditors.
 

How You Will Achieve It
  • Functional/Technical Knowledge:  Use technical knowledge of validation and cleaning discipline, including knowledge of industry practices and standards.  The focus is on overseeing defined processes.

  • Problem Solving and Innovation:  Provide solutions to a wide range of simple to moderately complex problems. May refer to precedents and policies. Able to gather, analyze and interpret information and identify cause and effect relationships.  Solutions are aligned with organization objectives.  Able to adapt and respond positively to situations and people in order to meet changing work area priorities.  Identify cost and compliance improvement projects.  Operate within established HR policies and guidelines.

  • Discretion, Latitude, Level of Independence:  Work under general direction.  Participate in determining objectives of assignments.  Independently determine and develop the approach to solutions.  Administer policies & procedures that affect assigned area(s).

  • Impact and Organizational Contribution:  Contribute to the completion of routine tasks.  Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources.  Monitor and manage the efforts of colleagues to achieve delivery of short-term goals.  Lead and motivate others, generating commitment and a shared sense of purpose.

QualificationsMust-Have
  • 2+ years of related validation/manufacturing experience or  BS/MS Chemical Engineering / Chemistry / related field

  • Effective written and oral communication

  • Good organizational skills

  • Knowledge of Microsoft Applications

Nice-to-Have

  • API manufacturing experience

  • Indirect leadership experience {e.g. testing/team Subject Matter Expert project lead, training lead)

  • Demonstrated proficiency in computerized systems (e.g., Trackwise/QTS, Labware/LIMS, Documentum/PDOCS)

  
 

PHYSICAL/MENTAL REQUIREMENTS

Able to spend frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access, including able to use hearing and eye protection

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Colleague must be willing to work off-shift and weekends when production/project demands require it

Relocation support available

Last Date to Apply for Job: October 12th 2021
    Eligible for Relocation Package: YES
    Eligible for Employee Referral Bonus: YES
    #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.

Manufacturing

#LI-PFE