Pfizer

APS Vaccine Filling Production Lead II - 1st Shift

Posted on: 15 Mar 2021

Kalamazoo, MI

Job Description

ROLE SUMMARY

The Production Lead II is responsible for providing leadership and direction to meet production demand and requirements. Liaison between work team and support groups to execute production schedules. Establish efficient processes, monitoring specific results, and improve identified process opportunities using IMEx, Right First Time (RFT) and Lean principles. Assist in identifying problems and communicating issues impacting production activities. Drives timely resolution to production floor obstacles and contributes to solutions using Method 1 and Quality Risk Management (QRM). Serve as an operations subject matter expert for the work team and Deviation Report Coordinator (DRC), where appropriate. Work with project teams to develop production related documentation, user requirements and to execute capital related activities. Work with procurement and packaging engineering to monitor component issues and conduct feasibility assessments/line trials as needed.

Production Lead II is also responsible for supporting the work team operation to ensure that applicable safety guidelines/policies are followed, and that all tasks are conducted in accordance with appropriate processing standards, such as FDA's current Good Manufacturing Practices (cGMPs).

ROLE RESPONSIBILITIES

Works in a complex integrated computerized manufacturing environment. Plans, coordinates and facilitates the work activities of work team colleagues and contractors by providing leadership and advice. Monitors, evaluates and revises operations activities/processes or manufacturing equipment to maximize quality and provides assistance. Has a thorough knowledge of department and organization policies and procedures. Serves on multiple intra-plant teams. This position is responsible to drive adherence to production schedules, direct day to day work team activities, and provide input to supervision on work team colleague performance. Performs necessary functions to convert raw material into product through complex integrated manufacturing processes. Maintains and improves work team processes to achieve optimal operating efficiency. Work is performed in strict compliance with manufacturing standards and all regulatory requirements.

Lead a diverse team in day-to-day vaccine manufacturing activities to ensure that quality output is being achieved.

Maintain a 24/7 schedule, which includes approving and denying vacation requests based on business needs.

Proficient use of PGS Learning Solution (PLS), Quality Tracking System (QTS), Plant Equipment Performance Systems (PEPS), and SAP are desired.

Work with Supervision to create a diverse, effective, and productive team through the selection and mentoring of our workforce.

Successful candidate must demonstrate personal leadership initiative, judgment and accountability in day-to-day work activities in addition to strong planning/organizational skills. Must possess strong communication skills and demonstrate integrity and cooperation in working with diverse colleagues and groups.

Experience in the operating area (formulation, filling, inspection, packaging or freeze handling) and strong technical skills are desired.

Ensures all members of the team are trained for their roles and tasks and ensures training compliance of the team.

Consistently makes significant contributions to the achievement of the team, plant and/or global objectives. Exemplifies and instills in others an Ownership mentality. Demonstrates active involvement in daily production operations. Maintains frequent contact with all stakeholders and impacted organizations concerning operations and production scheduling. Engages the right subject matter experts to help resolve unplanned events efficiently. Works and communicates well across the vaccine value stream.

QUALIFICATIONS

* Education: High school diploma / general education degree (GED) with an Associates Degree in technically related field of study preferred.
* Experience: Five to seven years related experience and/or training.
* Certificates, Licenses or Registrations: N/A
* Language Skills: Effective written and oral communication skills required. Demonstrated reading comprehension and writing proficiency at level that meets Job Summary requirements. Ability to effectively communicate with diverse individuals/groups resulting in desired outcomes.
* Mathematical Skills: Strong math skills with the ability to calculate percentages and develop basic graphs and spreadsheets.
* Reasoning Ability: Skill in analyzing information, problems, situations, practices or procedures to: Define the problem or objective; Identify relevant concerns or factors; Identify patterns, tendencies and relationships; Formulate logical and objective conclusions; and, Recognize alternatives and their implications.
* Physical Demands: Job tasks may include frequent bending, lifting, and twisting motions. Ability to stand upright for several consecutive hours. Absence of any medical restrictions which could restrict completion of all required duties. Additional demands are area specific.
* Work Environment: Colleague may be exposed to airborne particles which requires appropriate safety protection, noise levels may require protective hearing devices, eye protection required. Practices and promotes safe working environmental at all times. Area specific gowning will be required.

Other Job Details:

* Last Date to Apply for Job: March 22, 2021
* Additional Location Information: Kalamazoo, Michigan
* Eligible for Employee Referral Bonus

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.

Manufacturing

LI-PFE

Pfizer

New York, New York

Pfizer Inc. develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases under the Lyrica, Chantix/Champix, Eliquis, Ibrance, Sutent, Xalkori, Inlyta, Xtandi, Enbrel, Xeljanz, Eucrisa, BeneFix, Genotropin, and Refacto AF/Xyntha brands. The company also provides consumer healthcare products that comprise over-the-counter medicines, including dietary supplement products under the Centrum, Caltrate, and Emergen-C names; pain management products under the Advil and ThermaCare names; gastrointestinal products under the Nexium 24HR/Nexium Control and Preparation H names; and respiratory and personal care products under the Robitussin, Advil Cold & Sinus, and ChapStick names. In addition, it offers products that would lose or have lost marketing patent protection; branded generic products; generic sterile injectable products; biosimilars; and anti-infectives under the Lipitor, Premarin family, Norvasc, Lyrica, Celebrex, Viagra, Inflectra/Remsima, Zyvox, Vfend, Revatio, Inspra, Medrol, Sulperazon, Fragmin, Tygacil, Nivestim, and Retacrit, Ixifi Infliximab BS names.

Further, the company is also involved in the contract manufacturing business. It serves wholesalers, retailers, hospitals, clinics, government agencies, pharmacies, and individual provider offices, as well as disease control and prevention centers. The company has collaboration and/or co-promotion agreements with Bristol-Myers Squibb Company, Astellas Pharma US, Inc., and Oncolytics Biotech Inc.; licensing agreement with BionTech AG; strategic alliance with Verily Life Sciences LLC; and collaboration agreements with Pfizer, Merck & Co., Inc., and Eli Lilly & Company, as well as with Merck KGaA and Nektar Therapeutics to develop a therapy for treating pancreatic cancer. Pfizer Inc. was founded in 1849 and is headquartered in New York, New York.

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