Recipe Author Job Dearborn area,Michigan USA,Manufacturing / Production

Use Your Power For Purpose

The recipe author will become proficient with the standard functionality of MES (Manufacturing Execution System) Pharma Suite and work with production units to convert paper records to E (Electronic Batch Record). The E recipe author will focus on authoring and configuring master batch records, templates, revisions, validation and change controls of E Recipes at the Kalamazoo Manufacturing Site.

Use Your Power For Purpose

What You Will Achieve

The recipe author will define and analyze business requirements through meeting with production units and develop detailed designs to meet those requirements. They will provide initial training to production units during deployment. This role will provide troubleshooting assistance to operations, as well as ongoing data management. In this role it is critical to be on-site engaging with operations on a regular basis to ensure understanding of processes and gathering critical parameters.

The recipe author will need to have a proactive approach in managing their time and engaging the production units.

How You Will Achieve It

Responsibilities can include but not limited to:

Design, preparation and revision of Electronic Batch Records (E ).
Supporting end users on E execution and usage.
Manage E 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.
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.
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 E Issues.
Ensure all the performed activities comply with respective procedures.
Identify deviations/exceptions and escape 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.

Quality Management and Compliance

Ensure compliance of operations to cGMP, safety and Pfizer integrity principles at all stages of activity
Assist Manager in controlling tracking and periodic E procedure updates and manages emergency changes appropriately.

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.

Here Is What You Need (Basic Requirements)

Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.
Pharmaceutical experience
Certifications:

M1, Yellow Belt and/or Pfizer Human Performance methodology.
Computer

Skills:

HTML, Java, or object-oriented programming.
Focused in Systems Analyst/Data Management.
E /MES build experience.
Experience working in Quality Tracking Systems.

Physical/Mental Requirements

Ability to perform mathematical calculations and ability to perform complex data…