Pharma MES Master Batch Record Designer (Remote)

GMP Pros, Inc.; Omaha (NE); Remoto; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

GMP Pros, Inc. seeks a Master Batch Record (MBR) Designer to develop, configure, and maintain electronic Master Batch Records within a MES to support compliant and efficient production for pharma, biotech, food, and animal health sectors.

The role offers remote work with occasional on-site collaboration and requires prior biotech/pharmaceutical industry experience. Applicants must have hands-on eBR design experience and knowledge of GMP and 21 CFR Part 11, with strong communication and

Competenze

• 3–5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing with batch record exposure.
• Minimum 2–3 years of hands-on design with electronic batch records (eBR) like PAS-X or similar.
• GMP, FDA 21 CFR Part 11 and related regulatory standards familiarity.
• Experience mapping business processes using Visio or Lucidchart.

Mansioni

• Collaborate with project teams to translate requirements for PAS-X deployment across Oral Solids production.
• Translate design blueprints into GMBRs, MBRs, PMBRs, PVLs, and ESPs for deployment.
• Assist in Master Data creation and management.
• Support hardware/infrastructure integration (printers, scanners, clients).
• Test and troubleshoot designs in the DEV environment and assist PROD validation.
• Support Early Life Support and Hyper Care during deployment across site.
• Maintain project deliverables and milestone dates.

Conoscenze

Proactive

Adaptability

Relationship building

Team collaboration

Process improvement

Resilience under pressure

Fast learner

Motivating others

Formazione

Bachelor's degree in Life Sciences / related field

MES training or certification

Strumenti

PAS-X

Pharmasuite

Siemens OpCenter

Visio

Lucidchart

Descrizione del lavoro

GMP Pros, Inc. seeks a Master Batch Record (MBR) Designer to develop, configure, and maintain electronic Master Batch Records within a MES to support compliant and efficient production for pharma, biotech, food, and animal health sectors.

The role offers remote work with occasional on-site collaboration and requires prior biotech/pharmaceutical industry experience. Applicants must have hands-on eBR design experience and knowledge of GMP and 21 CFR Part 11, with strong communication and