Master Batch Record (MBR) Designer - 1099/W2

Are you a GMP Pro?!

• Are you a proactive doer?
• Do you need variety and change to keep from getting bored?
• Do you build relationships easily and are you able to communicate information so that it is easily understandable?
• Do you like working in a team supportive environment where others want to help you succeed?
• Do you try to find a better way for everything because that is the way it should be?
• Do you thrive in organized chaos and high-pressure situations?
• Do you quickly become an expert in any subject matter you are working in?
• Can you stay motivated and help motivate others in the face of adversity and change? Are you resilient?
  

The Master Batch Record (MBR) Designer will be presented with hard work, relentless challenges, and the pressure of high expectations. The MBR Designer is responsible for developing, configuring, and maintaining electronic Master Batch Records within a manufacturing execution system (MES) to support compliant and efficient production.

Be part of an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. Get the best of both worlds. Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company.

APPLICANTS MUST HAVE PRIOR EXPERIENCE IN BIOTECH, PHARMACEUTICAL, OR ANIMAL HEALTH INDUSTRIES TO BE CONSIDERED

Essential Duties:

• 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:

• 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.

Some other things that you will need to be successful:

• Experienced in an FDA-regulated environment.
• Excellent communication and organization skills, with an analytical and problem-solving mindset.
• Ability to multi-task and complete multiple projects on time.

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.

Work Environment Expectations

• This role can be remote with occasional on-site work