Software Developer

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Sr Engineer - Software

Thousand Oaks, CA 91320

Posted: 04/03/2024 Job Number: 38924

Job Description


Sr Engineer - Software


Top 3 Must Have Skill Sets:
  • Experience in PAS-X Werum
  • Experience with Drug Product Manufacturing
  • Attention to detail

Red Flags:
  • No PAS-X Werum experience
  • No biotech manufacturing experience

Responsibilities:
  • 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.
  • 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.
  • Revise/Create PVLs, GMBRs, ESPs
  • Communicate with manufacturing, PD, supply chain, QA
  • Provide troubleshooting support
  • Provide assessments for projects and NPIs

Skills:
  • Must have previous biopharmaceutical manufacturing experience. Demonstrable strong communication skills (verbal and written), “Right the First Time” quality-based mindset.
  • Significant experience with PAS X, Werum software for electronic batch records with some understanding of editing and validation
Basic Qualifications:
  • Doctorate Degree
OR
  • Master Degree and 3 years of Engineering experience
OR
  • Bachelor Degree and 5 years of Engineering experience
OR
  • Associate degree and10 years of Engineering experience
OR
  • High school diploma/GED and 12 years of Engineering experience

 

Pay range is $66 - $71 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

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