APN Operations Technician Assistant II (1st shift)

Pfizer • Kalamazoo, MI

6d • Onsite

About The Position

As the entry level role 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. This role is crucial in ensuring 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.

Requirements

• High school diploma / general education degree (GED) plus An associate degree, OR Veteran/Military experience OR Minimum of 12 months as Assistant Operations Technician
• Proficient in Department Core Competencies
• Fully trained in 2 Non Aseptic Roles and 1 Aseptic Role
• Ability to lift and lower up to 35 pounds.
• Extended periods of sitting, standing, walking, and repetitive motion.
• Physical flexibility to perform tasks in confined or graded spaces.
• Must be able to wear required safety gear such as hard hats, body harnesses, and face shields.
• Able to work in GRADE A/B/C/D cleanroom environments with appropriate gowning.
• Ability to perform calculations and interpret data for production metrics and quality control.
• Capable of analyzing operational data and identifying trends or issues.
• Must manage multiple projects and shifting priorities in a fast-paced environment.
• Demonstrated ability to lead teams, make decisions independently, and mentor others.
• Comfortable adapting to unexpected demands and tight timelines
• Permanent work authorization in the United States.

Nice To Haves

• Mechanical experience / knowledge
• Aseptic manufacturing knowledge

Responsibilities

• Safety Orientation & Safety OJT training
• LOTO / Safe work permits / Confined space Awareness
• Unit safety self-inspections
• 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
• Core process dedicated line assignment(s)
• Assigned core competencies
• Perform appropriate documentation entries
• Perform specific and accurate double checks
• Maintain area audit readiness
• Display cGMP’s 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)
• Exhibits leader behaviors in accordance with Pfizer Core Values including: Seizes Accountability, Grows Self, Adapt to Change, Self-Awareness, Commits to One Pfizer, and Peer Relationships
• Performs work in professional, self-directed, responsible, and timely manner
• Trains others when requested
• Maintains good attendance and punctuality/adhere to scheduled break and lunch times
• 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.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage
• eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED