Production Specialist ECA/ATEC R3 (12 hour Night Shift E7)

 

ROLE SUMMARY

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The Production Specialist- ECA/ATEC Operator is responsible for the operation of Parts Washers to clean equipment, machine components, tools and product. This person will also load, unload, monitor, assemble and dis-assemble setups, make minor repairs and use a variety of material handling assisting in the operating of automated parts washers. Will be required to operate learn and operate ATEC equipment to prepare commodities.

ROLE RESPONSIBILITIES

• May operate any of several automated parts washers to clean equipment, machine components, tools and product. Processing of machine parts for production lines. Operate parts washer controls and monitor process through sterilization cycles.
• Must be mechanically inclined with hands on filler setup experience.
• Recognize when processes, procedures, equipment, product, commodities, etc.… are out of specification. Failure to identify potential issues may result in spoiled batches, lots, loads, commodities, up to and including a re-inspection/recall.
• Learn and cross train in ATEC area to be able to prepare commodities for filling operations.
• Learn, understand, and operate the SKANFOG equipment to prepare equipment for the sterile core.
• Learn, understand, and operate the Autoclave in order to sterilize equipment for use in the aseptic core.
• Adhere to all SOPs, cGMPs, plant quality, safety, and documentation systems requirements.
• Cleans equipment and work area as needed.
• Must be able to perform various functions of a highly repetitive nature while maintaining concentration of task.
• Must adhere to all gowning/uniform requirements in assigned area. Become Aseptic Gowning Qualified, to unload commodity inside sterile core.
• Must be able to keep accurate records and production logs, as well as complete batch records as required.
• Must be a team player.
• Ability to multi-task from performing duties in ECA area or ATEC as needed

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
In your role, you will be accountable for activities involved in the assembly and packaging of finished goods including goods in cans, bottles, boxes, bags, blister pacts, or other similar containers. This work typically includes meeting product finishing scheduling, setting up, operating, maintaining and troubleshooting packaging equipment; monitoring, evaluating and adjusting processes or packaging equipment to maximize quality and efficiency. You will also be responsible for completing batch records and associated documentation and working in an integrated computerized manufacturing environment.

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 make decision about the methods and procedures that are the best fit for different work situations.

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

How You Will Achieve It

• Manage own time and professional development, be accountable for own results.
• Prioritize own workflow and may lead and allocate work of others and assist in establishing their priorities.
• Serve as key resource within area of expertise.
• Maintain process flow and documentation according to GMP(Good Manufacturing Practices) and Quality Standards.
• Advise and inform the operator in all GMP related procedures and all operational deviation.
• Verify daily schedule to assign priorities upon discussion with Unit Leader or Team Leader.
• Act as an interface between the operator and the coordination with other department's requests or services such as (medical pass and physical exams).
• Assist in providing input for personnel related tasks (i.e., attendance, performance).
• Coordinate and follow-up with the resources needed from support departments.
• Identify training operators needs and coordination with training department.
• Keep accurate records as needed for solution manufacture and prepares solutions as directed by work order.
• Document work in the work order packages as needed.
• Recognize when processes, procedures, equipment, product, commodities, etc. are out of specifications.
• Perform set-up, cleaning and operation of complex equipment, chemical testing, mixing drugs, filtering and drug weighing.
• Maintain accurate and detailed paperwork.
• Utilize basic mathematical skills including an understanding of the metric system (if required by a specific job).
• Load, unload, monitor, make minor repairs and use a variety of material handling assisting in the operating of assigned machines.

BASIC QUALIFICATIONS

• Previous experience in the ECA area, commodity prep, set-up technician, or similar role.
• Ability to function in a highly structured role requiring independent judgment.
• May work as part of a self-directed team requiring the ability to work well with others.
• Requires good basic mathematical skills including an understanding of the metric system (if required by a specific job).
• The ability to plan and organize work under time pressures.
• Ensure adherence to all plant safety rules in area of responsibility.
• Ability to comprehend and respond to verbal and written instructions/plant documents.
• Ability to work overtime as required.
• Previous manufacturing experience in a technical role required.
• High School Diploma Required.
• Minimum of 2 years-experience in a manufacturing technical role

PREFERRED QUALIFICATIONS

• Aseptic Qualified
• Trained in preparation of sterile components.
• Trained in Equipment Cleaning procedures.
• Familiar with Batch Record documentation, and adherence to SOP.

PHYSICAL/MENTAL REQUIREMENTS

• Use computer terminal 6 hours per shift
• respond to visual warning indicators
• respond to audible warning indicators
• respond to color or special visual indicators
• use powered material handling equipment
• work around moving equipment
• work with biological materials
• work with chemicals
• wear specialized protective clothing, wear a respirator, wear PPE (safety shoes/glasses/etc)
• work in hot or cold environment
• work in hearing conservation area
• Stand up to 8 - 12 hours per shift
• sit for up to 5-6 hours per shift
• regularly lift up to 35 pounds per activity 20 times per shift
• occasionally lift a maximum of 50 pounds per activity 10 times per shift
• occasionally may lift over 50 pounds with assistance
• walk, climb stairs, climb ladders/walk on catwalks.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

0% Travel required

Night Shift E7 2/2/3 rotation 7pm-7am

May require OT on non-scheduled days depending on production needs

Work Location Assignment: On Premise

Last day to apply: July 20th

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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