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Master Batch Record Designer
GMP Pros, Inc.®Master Batch Record Designer developing and maintaining electronic Master Batch Records for pharmaceutical companies. Collaborating with project teams to support compliant and efficient production processes.
About the role
Key responsibilities & impact- Work with a project team to understand business requirements for design and deployment of PAS-X across manufacturing and packaging for Oral Solids Dosage.
- Take design blueprints and translate into GMBRs, MBRs, PMBRs, PVLs, and ESPs for the deployment.
- Support the creation and management of Master Data.
- Support integration of hardware and infrastructure (printers, scanners, clients).
- Test and troubleshoot designs with end users in the DEV environment.
- Support verification and validation of designs in the PROD environment.
- Support Early Life Support and Hyper Care for deployment activities across the site.
- Maintain project deliverables and milestone dates.
Requirements
What you’ll need- Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering, or a related technical field.
- MES platform-based training or certification (e.g. Koerber PAS-X Training) preferred
- 3 - 5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing with exposure to batch record development.
- Minimum of 2 - 3 years of hands-on design experience with electronic batch record (eBR) systems such as PAS-X, Pharmasuite, Siemens opCenter, etc. (PAS-X preferred).
- Proven experience mapping business processes (e.g. Visio or Lucid Chart)
- Knowledge of GMP, FDA 21 CFR Part 11, and other relevant regulatory standards.
- Practical experience working in a project environment with a project team.
- Excellent communication and organization skills, with an analytical and problem-solving mindset.
- Ability to multi-task and complete multiple projects on time.
Benefits
Comp & perks- Pre-Employment Requirements: Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references.
- Subject to motor vehicle report review.
- Maintain valid driver’s license and endorsements as required per position.
- Pass pre-employment/contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.
- Successfully complete and maintain any required safety certification and testing on an annual basis.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
design blueprintsGMBRsMBRsPMBRsPVLsESPsMaster Data managementeBR systemsbatch record developmentbusiness process mapping
Soft Skills
communication skillsorganizational skillsanalytical mindsetproblem-solving mindsetmulti-taskingproject management
Certifications
Bachelor’s degree in Life SciencesBachelor’s degree in Pharmaceutical SciencesBachelor’s degree in Industrial EngineeringBachelor’s degree in Chemical EngineeringBachelor’s degree in Mechanical EngineeringBachelor’s degree in Automation EngineeringKoerber PAS-X Training