EBR Recipe Author Manager

Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.
Our science and risk-based compliant quality culture is innovative and customer oriented.
Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
What You Will Achieve The EBR Recipe Author Manager reports to the Connected Factory Sr Manager/TL.
The EBR Recipe Author manager is expected to be experts in the overall functionality of MES (Manufacturing Execution System) PharmaSuite and work with developers, above site colleagues and production units to convert paper records to EBR (Electronic Batch Record) as well as mentor other grade levels within the organization.
The EBR Recipe Author Manager will focus on the direct authoring and configuring master batch records and templates, revisions, validation, and change controls of EBR Recipes at the Kalamazoo Manufacturing Site.
The EBR Recipe Author Manager will have extensive knowledge of SAP Functions BOM, PV and IDOC management to assist in troubleshooting issues and managing interfaces between the systems.
The EBR Recipe Author Manager will define and analyze business requirements through meeting with production units and develop detailed designs to meet those requirements.
They will direct the coordination of standard work practices assuring alignment of supporting systems and reports.
They will be providing support to the site as part of the sustainment team post go-live of production units that includes troubleshooting and escalation of Business Technology (BT) tickets.
In this role it is critical to engage with operations on a regular basis to ensure understanding of processes and gathering critical parameters as well as supporting hypercare for go-live activities.
The recipe author will need to have a proactive approach in managing their time and engaging the production units.
How You Will Achieve It Demonstrated ability in EBR Recipe Author Responsibilities.
Design, preparation and revision of Electronic Batch Records (EBR).
Supporting end users on EBR execution and usage.
Manage EBR design and configuration changes, process reviews and alignment with associated documentation used to the continuity plan.
Initiating and own change controls related to documents and equipment.
Ensuring their closure and implementation of changes within specific time as well as track EBR project change controls for team.
Participate in process mapping of business processes.
Engagement of SME’s, Leads and Operators to ensure critical parameters are being captured.
Point of contact for electronic batch record manufacturing issues as part of sustainment team.
Escalation of electronic manufacturing execution issues to subject matter expert or supporting team.
Having thorough knowledge of manufacturing execution system (MES), recipe design, baseline configuration, create and execute functional verification protocols.
Handling of Shop floor troubleshooting in SAP- AMPS interface for Electronic Batch Records.
Act as part of sustainment team to support continuous improvement and batch record changes as applicable.
BT ticket follow ups and ensuring its resolution with EBR Issues.
Ensure all the performed activities comply with respective procedures.
Identify deviations/exceptions and escalate to leadership by appropriate procedures.
Adherence to safety procedure/GMP & GDP practices.
Reassess and participate in an agile change environment to enhance the process at intervals to eliminate non-value-added activities and drive continuous improvement including supporting projects and deployments.
Participate in cross functional teams to support, enhance, and upgrade AMPS.
Technical document writing for procedures, jobaids and functional verification protocols creation and execution.
Assist in the work required to train, execute, track and reporting duties for other colleagues of the EBR team.
Responsible for Business Configuration Documentation (BCD) and update as required.
Responsible for the Business Continuity Plan adherence (BCP) and update as required.
Quality Management and Compliance: Ensure compliance of operations to cGMP, safety and Pfizer integrity principles at all stages of activity To participate in internal & external (regulatory & non-Regulatory) audits.
Assist Manager in tracking EBR procedure updates, periodic review of EBR procedures and emergency changes as required.
Training: To attend the training of all applicable procedures as per schedule.
Colleague will be responsible for cross training to be able to support all AMPS areas being deployed or sustained.
To develop and update content for AMPS EBR training for new hires tothe EBR recipe authoring team.
As a EBR Recipe Author Manager, demonstrated additional responsibilities and competencies: Leverages key stakeholders across DP, Quality, SCO, BT, and PGE to achieve goals.
Provides guidance and sets strategic vision as an SME and other systems that have scope falling under EBR.
Mentors other recipe authors in development, design and system usage and functionality.
Leads Limited Duration Teams and other cross-functional teams in defining and implementing components of an EBR strategy.
Leverages best practices at other sites and incorporates those into the site EBR strategy while influencing and insuring alignment with the corporate vision.
Functional and Technical Knowledge Applies extensive technical and industry-specific expertise and has extensive knowledge of the requirements of other related disciplines.
Demonstrated skills in leading, planning, and developing successful business processes/business units.
Mastery and demonstrated application of SCO systems and functional knowledge.
Problem Solving and Innovation Leads and/or develops solutions to complex problems which require the regular use of ingenuity, innovation, and creativity.
Ability to establish precedents and policies.
Ability to gather, analyze and interpret, relate and compare information from multiple sources and identify cause and effect relationships including data from outside functional area.
Qualifications Must-Have Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience.
OR an Associate's degree with 8 years of experience.
OR a Bachelor's with at least 5 years of experience.
OR Master's Degree with more than 3 years of experience OR a PhD with 0+ years of experience.
Computer Skills: SharePoint, Proficiency in Microsoft office suite products (Word, Excel, Power point) Language Skills: Effective oral and written communications skills Nice-to-Have Pharmaceutical experience Certifications: M1, Yellow Belt and/or Pfizer Human Performance methodology.
Computer Skills: EBR Recipe Design and Authoring, PharmaSuite, AMPS (MES), HTML, Java, or object-oriented programming.
Focused in Systems Analysis/Data Management.
Experience working in Quality Tracking Systems.
PHYSICAL/MENTAL REQUIREMENTS Ability to perform mathematical calculations and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Occasional travel may be required (<5%) Work Location Assignment: On Premise Other Job Details: Last Date to Apply for Job: March 31, 2024 Eligible for Relocation Package Eligible for Employee Referral Bonus The annual base salary for this position ranges from $93,500.
00 to $155,900.
00.
In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.
5% of the base salary and eligibility to participate in our share based long term incentive program.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
Learn more at Pfizer Candidate Site – U.
S.
Benefits | (uscandidates.
mypfizerbenefits.
com).
Pfizer compensation structures and benefit packages are aligned based on the location of hire.
The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
This position requires permanent work authorization in the United States.
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