Sr Software Engineer

Summary:

Routinely perform complex electronic data entry according to Standard Operating Procedure (SOP).

Specific responsibilities include creation and validation of electronic batch records (EBR) per procedures using Manufacturing Execution System (MES) and ERP.

Responsibilities:

Support paper on glass manufacturing batch record process
Translation and understanding of process specifications established by development teams into source documents (paper or electronic) utilized by production teams
Creation of Parameter Value Lists in EBR
Editing and creation of GMBRs in EBR
Translation of instruction from paper sources to electronic systems
Internal support operations (eg, data verification, document management, SOP revisions)
Manufacturing support focused on Electronic Batch Record (EBR) generation, editing, real-time troubleshooting and managing the EBR validation for new or modified processes.
Assisting in the implementation of new MES functionality.
Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.

Skills:

Must have previous biopharmaceutical manufacturing experience. Demonstrable strong communication skills (verbal and written), “Right the First Time” quality-based mindset.
Significant experience with Client X, Werum software for electronic batch records with some understanding of editing and validation

Top 3 Must Have Skill Sets:

Experience in Client-X Werum
Experience with Drug Product Manufacturing
Attention to detail

Education and Experience:

Targeting Bio-Pharma background.
2+ years of drug product/manufacturing experience.
BS Engineering or Biological Sciences