Production Lead I, Inspection, Packaging, Freeze Handling Vaccine (2nd Shift).
- Full-Time
- Kalamazoo, MI
- Pfizer
- Posted 3 years ago – Accepting applications
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