Process Specialist III - Vaccine Formulation Facility

Pfizer Inc.

Kalamazoo, MI

Job posting number: #7135289 (Ref:pf-4876056)

Posted: March 21, 2023

Application Deadline: Open Until Filled

Job Description

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

You will monitor and respond to basic functioning needs of area equipment, i.e. line speed, feeding product, line clearances, cleaning, loading or unloading materials adhering to all SOPs, cGMPs (current Good Manufacturing Practices), plant quality, safety, and documentation systems requirements.

As part of the Technical Operations team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

You will assist with training others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to patients.

ROLE SUMMARY

The Process Specialist III is responsible for providing leadership and detailed technical training to Drug Product work team colleagues. Liaison between work team and maintenance for repairs and preventative maintenance. Develop, maintain and train work team colleagues on operator care task sheets. Establish efficient processes, monitoring specific results, and improve identified process opportunities using Right First Time (RFT), IMEx, and Lean principles. Maintain manufacturing equipment at optimal operating efficiency. Assist in identifying problems and solutions using Method 1 and Quality Risk Management (QRM).

Serve as technical subject matter expert (SME) for the work team on equipment related deviations. Work with engineering by participating in developing equipment specifications, user requirements, capital scope development, FAT/SAT support and qualification activities. Work with procurement and packaging engineering to monitor component issues and conduct feasibility assessments/line trials as needed.

Process Specialist III is also responsible for supporting the work team operation to ensure that applicable safety guidelines/policies are followed, and that all tasks are conducted in accordance with appropriate processing standards, such as FDA's current Good Manufacturing Practices (cGMP’s). Must consistently demonstrate Pfizer values and leadership behaviors. Works in a complex integrated computerized environment which includes manufacturing and packaging operations or involves multiple highly automated and integrated packaging lines. Plans, coordinates and facilitates project and efficiency improvement activities within work teams by providing leadership and advice. Monitors, evaluates and revises operations activities/processes and manufacturing equipment to maximize quality and provide technical assistance. Has a thorough knowledge of department and organization policies and procedures. Serves on intra-plant teams. Responsible to maintain and make repairs on integrated complex equipment. Performs necessary functions to convert raw material into product through complex integrated manufacturing and packaging processes.

Diagnoses operating difficulties, makes repairs, adjustments and troubleshoots equipment. Work is performed in strict compliance with manufacturing standards and all regulatory requirements.

How You Will Achieve It

Functional/Technical Knowledge:

Successful application and demonstration of industry practices and standards. Self-directed and proactive use of technical applications on large scope applications/projects. Identifies/executes significant process improvements.

Problem Solving and Innovation:

Develops solutions to complex problems which require the regular use of ingenuity, innovation, and creativity. Ability to gather, analyze, and interpret, relate and compare information from multiple sources, and identify cause and effect relationships. Ensures solutions are consistent with organizational objectives.

Discretion, Latitude, Level of Independence:

Ability to work independently. Follows specific, detailed instructions.

Impact and Organizational Contribution:

Guides the successful completion of major programs and may be in a team or project leadership role. Contributes to achievement of team, plant and/or global goals. Ensures that projects are completed on schedule and within budget. Failure to achieve results will have a significant impact on departmental objectives.

Teamwork/Influence:

Represents the organization as the contact on projects. Leads teams of diverse makeup including cross-functional departments and colleague levels. Interacts with senior internal and/or external personnel on matters often requiring coordination between organizations. Conducts briefings and participates in technical meetings for internal and external representatives concerning specific operations.

Time Span of Work:

Daily tasks and deliverables. Results can usually be measured on daily or weekly basis.

QUALIFICATIONS

Education:

High school diploma / general education degree (GED) with an associate degree in technically related field of study preferred. ·

Experience:

Three to five years related experience and/or training or a 4-year Bachelor's Degree.

Language Skills:

Effective written and oral communication skills required. Demonstrated reading comprehension and writing proficiency at level that meets Job Summary requirements. Ability to effectively communicate with diverse individuals/groups resulting in desired outcomes. ·

Mathematical Skills:

Strong math skills with the ability to calculate percentages and develop basic graphs and spreadsheets. ·

Reasoning Ability:

Skill in analyzing information, problems, situations, practices or procedures to: Define the problem or objective; Identify relevant concerns or factors; Identify patterns, tendencies and relationships; Formulate logical and objective conclusions; and Recognize alternatives and their implications.

Physical Demands:

Job tasks may include frequent bending, lifting, and twisting motions. Ability to stand upright for several consecutive hours. Absence of any medical restrictions which could restrict completion of all required duties. Additional demands are area specific. ·

Work Environment:

Colleague may be exposed to airborne particles which requires appropriate safety protection, noise levels may require protective hearing devices, eye protection required. Practices and promotes safe working environmental at all times. Area specific gowning will be required.

  • Math and reading skills required for SOP, GMP and Batch Record comprehension.

  • Ability to contribute to department success in a team environment and perform tasks at a productive level under demanding conditions is mandatory.

  • Must be self-motivated and willing to learn new and changing responsibilities.

  • Requires a demonstrated ability to self-direct daily activities to meet production schedule.

 PHYSICAL/MENTAL REQUIREMENTS

Standing, lifting, and walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This position supports a 24x7x365 operation.

  • Day Shift: This position will align work schedule to support a 6am to 6pm team with a rotating 3-3-2 schedule.

  • This schedule provides 2 consecutive weekends unscheduled followed by 2 scheduled weekends.

  • Holiday and overtime may be required to meet business needs.

Other Job Details:

  • Last Date to Apply for Job: April 3, 2023.

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



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.


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