MES EBR Recipe Author

Job Description

MUST HAVE

BS in science-related discipline preferred and 5+ years experience in biotech work environment.

Prior experience with full Recipe Authoring/Configuration using Controls/MES protocol. Prefer experience with creation of fully unique recipes/objects.

Experienced with Batch Process Definition, Work Instruction configuration, Recipe Step pathways, Equipment/Class creation/management, and Parameter/behavior configuration, including referrals and deferrals.

Previous experience in implementing MES systems/modules (e.g. material dispense, equipment tracking, eLOG creation) and/or automated system (Delta V integration).

Prior experience in an IT Enginnering role supporting the manufacture of pharmaceuticals in a regulated and/or cGMP production environment preferred.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ~~~ .

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Skills and Requirements

Significant experience with Emerson Syncade platform, preferrably in a pharmaceutical environment.

DAY TO DAY

Develop new MES eBR records while meeting all user and process requirements in a timely manner. Production recipes may be configured through the use of standard library objects or unique recipe objects.

Revise MES eBR records, where applicable, through established change control processes.

Develop associated material eDispense records (e.g. weigh & dispense) with specified Bill of Material (BOM) properties/parameters to support manufacturing dispensing needs.

Collaborate with internal stakeholders such as Manufacturing, MSAT, Materials Management, QC to ensure customer/user requreirements are met and are incorporated appropriately.

Support testing and validation activities for new and revised eBRs, operations, and electronic work instructions, etc.

Assist in the meeting of task interim milestones and overall schedule. Understand current requirements and schedule for completion. Balance multiple requirements to meet schedule expectations. Elevate concerns of schedule slip prior to missing delivery date.

Work with peer RAs to provide technical support as applicable.

Assist in fulfilling requirements of quality records such as Controls Event Logs (CELs) and Change Controls tasks, while operating within established Change Control procedures. null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to ~~~.