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 be responsible for generating work orders and ensuring that work is completed correctly in a timely manner. Your knowledge in the domain will help in providing detailed technical training to colleagues. You will support 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 current Good Manufacturing Practices (cGMPs).
As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Operations Specialists are responsible for providing detailed technical training for their operating unit(s) and own documentation and work practices for these units. Specialists provide SME level support for investigations, preventative actions, and continuous improvement. The role exists throughout drug product operations areas including injectable filling, freeze dry, manufacturing, prep, aseptic services, packaging, inspection, biological operations, non-sterile liquids, powders, and gelfoam.
In each area, specialists serve a key compliance role within the unit ensuring new colleagues are trained properly and using a robust and standard system. Specialists also maintain work certification to fill in as shop floor operators as well as other roles when needed to support the business. Some of common elements for the Operations Specialists across units include:
Works in a complex integrated computerized manufacturing environment
Maintains a thorough working knowledge of department and organization policies, procedures and personnel
Ensure unit policies, procedures, and training systems are optimized and effectively implemented within the unit
Develops effective unit onboarding and training systems and manages curricula enrollment and progress
Participates as a key contributor for investigations and troubleshooting activities such as M1’s and QARs
Ensures the operating unit is audit ready and demonstrating all GMP behaviors
Takes a lead role in IMEx, M1, 5S, and CI activities
Effectively communicates with team members on the shop floor and with unit management
Demonstrates Pfizer values and leader behaviors
May also serve as a technical SME for equipment, maintenance, and project work in some areas
Role Responsibilities
Overview: As the entry level role in this career path, the colleague is expected to show progression towards all the items below and competency on a growing number of them as the duration in the role progresses.
EHS
Displays a commitment to safety in daily work and planning and models desired safety behaviors
Has completed safety orientation for area and all area specific OJT training related to safety
Understands & trains colleagues on EHS requirements (ie. LOTO / Confined Space Entry / Safe Work Permit / Bump Test / Hot Work)
Supports unit safety self-inspections (helps addressing deficiencies)
Implements safety improvements (i.e. Good Catches, manages EHS WOs)
Works with unit safety team and/or Unit Leadership addressing safety issues
Job Safety Assessment (Training / In-Progress)
Participates in safety initiatives and unit safety teams and routinely suggests safety improvements
GMP
Maintains all necessary gowning and SPS certification
Maintains personal training requirements (at or above unit goals) and manages unit training including:
Direct technical training of new colleagues
Managing colleagues though training requirements in PLS and provides unit progress reports
Managing curricula enrollments and curricula content including SOP and OJT creation and revision
Trains and mentors team on SOPs, behaviors, and documentation handling practices
Understands Pfizer PHP principles
Ensures working areas are audit-ready state & maintains good housekeeping with knowledge of 5S standards
Assists Operations & QA with investigations and corrective action identification and implementation as requested
Operations
Is experienced and knowledgeable of all operational areas of responsibility
Can assume role of operator as needed to support day to day floor operations
Knowledgeable of standard work IMEx and CI tools
Identify / implement unit improvements (i.e. safety, process, cost reduction, efficiency, Zero Defect)
Participates in Green or Black belt projects and is training toward a Yellow belt
Manages some unit supply ordering
In some areas, serves as a technical SME for equipment and capital work with enabling organizations
Other:
Performs work in professional, self-directed, responsible, and timely manner
Supports unit/site initiatives
Adheres to Pfizer policies and procedures
Is aware of Pfizer Core Values including: Acts Decisively, Seizes Accountability, Grows Self, Adapt to Change, Self Awareness, Commits to One Pfizer, and Peer Relationships and can demonstrate them
Qualifications
Must-Have
- High School Diploma or GED
- 4+ years of experience
- Demonstrated good oral and written communication skills
Nice-to-Have
- Mechanical experience/aptitude
- Experience with Pfizer computer systems (MS office, PLS, QTS, PDOCS)
PHYSICAL/MENTAL REQUIREMENTS
Physical Demands:
lifting/lowering up to 55 pounds, working in high elevations (above 6 feet), and reaching/standing/walking/stooping/crawling.
Able to wear safety PPE (Hard hat, body harness, face shield)
Able to work under full clean room (GRADE A/B/C/D) environments with appropriate gowning
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Positions is for third shift, 10:00pm- 6:30am. Specific shift schedules may vary by specific operational area. Weekend, holiday, and overtime may be required to meet business or customer needs.
OTHER JOB DETAILS
Last Date to Apply for Job: 2/28/24
Work Location Assignment: On Premise
The salary for this position ranges from $23.95 to $39.92 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Michigan - Kalamazoo location.
Relocation assistance may be available based on business needs and/or eligibility.
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
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