Process Technician 1 (2nd Shift)
Process Technician 1 (2nd Shift)
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Job Description
Use Your Power for Purpose
Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on members who understand the importance and impact of their role in Pfizers mission. Patients need colleagues like you who take pride in their work and always strive to improve outcomes. You will help ensure that patients and physicians have the medicines they need when they need them.
What You Will Achieve
In this role you will:
Take responsibility for individual contributions to achieve team deliverables working effectively as a team member and coordinating with others.
Manage personal time and professional development being accountable for results.
Follow standard procedures to complete tasks of varying scope sequence and complexity within the agreed timeframe.
Identify and solve moderately routine problems.
Complete assignments with moderate supervision using established procedures referring deviations from standard procedures to the supervisor.
Ensure work is reviewed for accuracy quality and adherence to standards.
Prepare and operate various components materials equipment and machines in your assigned area ensuring adequate inventory of parts and materials before starting a production run.
Adhere strictly to all plant safety and current Good Manufacturing Practices (cGMP) regulations.
Perform in-process quality inspections and seek to implement process and safety improvements.
The Biological Operations Tech role is responsible for processing raw materials (i.e. human and equine blood and plasma) into Stroma to be used in the formulation of ATGAM Purified Drug Substance by means of a large-scale biologic separation processes (i.e. centrifugation). Techs may also perform work on other processing steps related to other products run in that area. Work is performed in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e. GMPs & OSHA). This job includes the following functions:
Performing unit operations in the biological processing area with a variety of different equipment types (tanks pumps centrifuges scales filters freeze dryers etc.)
Washing sanitizingand cleaning facilities and equipment
Handling Charging and packaging materials
Monitoring process parameters and batch end reportsfor quality or equipment concerns
Utilizingcomputer skills to interact with multiple complex PLC and SCADA systems
Collaboratingwith maintenance and engineers totroubleshootequipment and perform TPM tasks
Supportingdevelopment andexecution of capital projects corrective actions and continuous improvement ideas
Demonstratinggrowth mindset to share best practices & utilize downtime effectively
Workingsafely and compliantly following all applicable SOPs and standards including recording of GMP documentation
Completing and maintaining all required training on time
Demonstrating ownership and accountabilityof theproduction schedule and product quality
Executing in-process quality inspections
Other duties as assigned by the supervisor
Overview: As the entry levelrole 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
Safety Orientation&Safety OJTtraining
LOTO / Safe work permits / Confined space Awareness
Unit safety self-inspections
GMP
GMP record entries
Gowning access (Certification completed)
Meets daily GMP requirements - with assistance
Maintains training documentation (PLS & Curricula)
Alarm response & notification awareness
BIOLOGICAL OPERATIONS
Stroma process and Blood Room operations (with assistance)
Setting up and operating biological operations equipment (with assistance)
Monitoring process performance and making appropriate documentation entries
Weighing and charging operations with biological materials
Perform specific and accurate double checks
Can perform disposals
Weekend Rotation (participation)
Maintain area audit readiness
Display cGMPs at all times
Identify issues respond and escalate appropriately
Complete andaccuratehandoffs
Operatorcare activities
Facility cleaning for routine and special cause events
Batchrecordreview
Other:
Practices leader behaviors in accordance with Pfizer CoreValues including: Seizes Accountability Grows Self Adapt to Change Self Awareness Commits toOne Pfizerand Peer Relationships
Performs work in professionalself-directed responsible and timely manner
Here is what you need
(Minimum Requirements)
High school diploma / general education degree (GED) ORVeteran/Military experience ORSix months of relevant work experience in a manufacturing or GMP facility (e.g. current or previous Pfizer colleague or contractor or similar)
Mechanical experience/aptitude
Experience handling biologic substances APIs or drug products
Bonus Points If You Have
(Preferred Requirements)
Previous experience in cGMPs (current Good Manufacturing Practices) environment
Proficiency in using manufacturing software and tools
Ability to adapt to changing priorities and work in a fast-paced environment
Demonstrated leadership skills and ability to mentor team members
PHYSICAL/MENTAL REQUIREMENTS
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 clean room (GRADE C/D) environments with appropriate gowning
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Positions are staffed across all three shifts. Specific shift schedules may vary by specific operational area.
Weekend holiday and overtime may be required to meet business or customer needs.
Work Location Assignment:On Premise
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 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.
Required Experience:
IC
Employment Type
Full-Time
