Production Lead I, Inspection, Packaging, Freeze Handling Vaccine (2nd Shift).

  • Full-Time
  • Kalamazoo, MI
  • Pfizer
  • Posted 3 years ago – Accepting applications
Job Description

ROLE SUMMARY

Production Leads are responsible for providing leadership and direction to meet production demands and requirements. These roles are present across all areas of Drug product operations including injectable filling, freeze dry, manufacturing, prep, aseptic services, packaging, inspection,freeze handling, biological operations, non-sterile liquids, powders, and gelfoam.

In each area, production leads serve as liaison between the unit team leader and sr. manager and the shop floor operators and take on responsibility for ensuring the shift is operating efficiently and in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e., GMPs & OSHA). In addition, production leads are role models and experts for their shift and can fill in across roles when needed and improve the overall work of their colleagues. Some of common elements for the production lead across units include:

  • Works in a complex integrated computerized manufacturing environment (MBR, SAP, EBR)

  • Assumes responsibility for adherence to production schedules and direct day to day work team activities

  • Works with other groups (operations, maintenance, scheduling, management, technical support, logistics) to ensure production needs are met and makes necessary adjustments when required

  • Monitors, evaluates and revises operations activities/processes and manufacturing equipment

  • Maintains a thorough working knowledge of department and organization policies, procedures and personnel

  • Mentors and develops colleagues while providing input to supervision on performance

  • Participates as a key contributor for investigations and troubleshooting activities such as M1’s and QARs

  • Represents the operations area on capital projects, new product introductions, and continuous improvement projects (including equipment specification, IQ/OQ/PQ, FAT/SAT work, etc.)

  • Ensures the operating unit is audit ready and demonstrating all GMP behaviors

  • Leads by example and holds team accountable for safety driven behaviors

  • Represents the unit and partners with planning to set a production plan and allocates manpower to meet that plan

  • 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

ROLE RESPONSIBILITIES

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

  • 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

  • Can perform LOTO / Safe work permits / Confined space Awareness for area

  • Conducts unit safety self-inspections

  • Has Job Safety Assessment Awareness

  • Participates in safety initiatives and unit safety teams and routinely suggests safety improvements

GMP

  • Maintains all necessary gowning and SPS certification

  • Executes GMP record entries, mentors team on record entries, and manages production ticket corrections for unit

  • Reviews and requests SOP and document revisions as needed to improve operations and compliance

  • Ensures working areas are audit ready state and maintains good housekeeping

  • Assists QO in gathering pertinent information for quality investigations

  • Understands Pfizer PHP principles

  • Trains and mentors team on SOPs, behaviors, and documentation handling practices

  • Maintains own PLS & training documentation and assists unit in managing training completions and assignments

Operations

  • Is experienced and knowledgeable of all operational areas of responsibility

  • Performs SAP transactions and assists in unit documentation

  • Can assume role of operator or TL as needed to support day to day floor operations

  • Maintains good attendance and punctuality & Manages unit production schedule & lunch/break times

  • Is responsible for filling out the daily shift report and ensuring information is passed on to incoming shifts

  • Serve as technical subject matter expert for the work team and provide support for equipment related deviations

  • Serve as Liaison between work team and maintenance for repairs and preventative maintenance

  • Takes an active role in managing non-routine situations such as schedule changes, cleaning activities (6 week, post construction, etc.), line trials, etc.

  • Supports IMEx and change initiatives

Other:

  • Performs work in professional,self-directed, responsible, and timely manner

  • Support unit/site initiatives

  • Adhere to Pfizer policies and procedures

QUALIFICATIONS

Education and Experience:

High school diploma / general education degree (GED) plus

  • An associate degree, OR

  • Veteran/Military experience, OR

  • 3 years of relevant work experience in a manufacturing or GMP facility (e.g. current or previous Pfizer colleague or contractor or similar) or with leadership responsibilities

In addition, the following skills are preferred:

  • Mechanical experience/aptitude

  • Experience with computer systems (MS office)

  • Mathematical and reasoning skills

  • Written & oral communication skills

Is aware of Pfizer CoreValues including: Acts Decisively, Seizes Accountability, Grows Self, Adapt to Change,Self Awareness, Commits toOne Pfizer,and Peer Relationships and can demonstrate them

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

Works a 10-4 work schedule. Over a four week period, works Tue -Thu (10 days), off Friday - Mon (4 days) works Tue-Thu (10 days), off Friday-Mon (4 days), Schedule subject to change weekend, holiday, and overtime may be required to meet business or customer needs. This operation will work 24x7x365.

Last Date to Apply for Job: November 16th 2021
Eligible for Relocation Package: NO
Eligible for Employee Referral Bonus: YES
#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

#LI-PFE
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