APN Operations Technician Assistant II (3rd shift)
Kalamazoo, MI - USA
Job Summary
ROLE RESPONSIBILITIES
Overview: As the entry levelrole in the Aseptic Manufacturing 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:
Safety Orientation& Safety OJTtraining
LOTO / Safe work permits / Confined space Awareness
Unit safety self-inspections
GMP:
GMP record entries
Aseptic and non-aseptic gowning access (Certification completed)
Meets daily GMP requirements - with assistance
Successful media fill (also known as SPS) participation
Maintains training documentation (PLS & Curricula)
Alarm response & notification awareness
DailyOperations:
Core process dedicated line assignment(s)
Assigned core competencies
Perform appropriate documentation entries
Perform specific and accurate double checks
Maintain area audit readiness
Display cGMPs at all times
Preparation of next production batch
Knowledgeable of Aseptic area operations
Identify issues respond and escalate appropriately
Maintain aseptic qualification requirements and display appropriate aseptic behaviors
Qualified trainer
Complete and accurate handoffs
SAP / EMS/SCADA Proficient
Participate in Area Audits - GMP/5S
Operator Care and TPM activities
Six week post- construction quarterly and special cleans
Batch Record Review
Equipment Functional testing (participation)
Other:
Exhibits leader behaviors in accordance with Pfizer CoreValues including: Seizes Accountability Grows Self Adapt to ChangeSelf-Awareness Commits toOne Pfizerand Peer Relationships
Performs work in professionalself-directed responsible and timely manner
Trains others when requested
Maintains good attendance and punctuality/adhere to scheduled break and lunch times
QUALIFICATIONS
Education and Experience:
High school diploma / general education degree (GED) plus
An associate degree OR
Veteran/Military experience OR
Minimum of 12 months as Assistant Operations Technician AND
Proficient in Department Core Competencies; AND Fully trained in 2 Non Aseptic Roles and 1 Aseptic Role
Preferred Qualifications:
Mechanical experience / knowledge
Aseptic manufacturing knowledge
Use Your Power for Purpose
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 Pfizers mission. You will help to ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated as it directly influences the availability of essential medications. Your dedication and agility are crucial in maintaining the high standards of our manufacturing processes. By continuously striving for excellence you contribute to the overall mission of delivering life-saving treatments to those in need. Your commitment to improving outcomes ensures that our breakthroughs reach the patients who depend on them.
What You Will Achieve
Take responsibility for individual contributions to achieve team deliverables represent the work group within department teams and foster a positive team environment.
Manage personal time and professional development prioritize workflow and assist less-experienced colleagues in prioritizing their tasks.
Complete assignments based on established procedures identify delivery and process improvements troubleshoot issues and provide direction and training to team members.
Share knowledge within and across multiple work groups and deliver comprehensive technical training to colleagues.
Proactively identify and resolve non-routine problems making decisions between multiple options in a structured environment.
Work under general supervision complete recurring assignments independently and refer new or unusual problems to the supervisor.
Ensure non-standard work is reviewed for sound technical judgment and hold oneself accountable to Pfizer standards guidelines and values.
Generate work orders ensure tasks are completed accurately and promptly and maintain compliance with safety guidelines and processing standards like cGMPs.
Adapt standard methods and procedures identify necessary delivery and process improvements and determine suitable methods for various work situations.
Maintain accurate records monitor equipment usage collaborate with supervisors on investigations and process improvements and generate reports to assess training needs and track progress.
PHYSICAL/MENTAL REQUIREMENTS
Lifting/Lowering: Ability to lift and lower up to 35 pounds.
Mobility: Extended periods of sitting standing walking and repetitive motion.
Flexibility: Physical flexibility to perform tasks in confined or graded spaces.
PPE Compliance: Must be able to wear required safety gear such as hard hats body harnesses and face shields.
Cleanroom Gowning: Able to work in GRADE A/B/C/D cleanroom environments with appropriate gowning.
Mathematical and Reasoning Skills: Ability to perform calculations and interpret data for production metrics and quality control.
Complex Data Analysis: Capable of analyzing operational data and identifying trends or issues.
Multitasking and Prioritization: Must manage multiple projects and shifting priorities in a fast-paced environment.
Leadership and Decision-Making: Demonstrated ability to lead teams make decisions independently and mentor others.
Change Orientation: Comfortable adapting to unexpected demands and tight timelines
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
This shift has rotating weekend work.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.
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 providers 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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
IC
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.