Master Batch Record (MBR) Designer - 1099
Master Batch Record (MBR) Designer - 1099
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Job Description
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.
Essential Job Functions
- Design and create GMBRs MBRs ESPs and PVLs to support client with Global deployment of MES.
- Author and create designs according to client standards and best practices.
- Support creation and input of Master Data.
- Report to Center of Excellence project team and take direction from program-level management.
- Collaborate with individual site teams according to local deployment strategies.
- Attend and support regular cadence of site-level meetings to include project review(s) periodic standup(s) periodic status review(s) design review(s) and working sessions.
- Give informed input on design strategy based on industry best practice.
- Adhere to all design and project timelines.
- Actively communicate design and project risks and escalate to relevant GMP Pros stakeholders.
- Support GMP Pros governance through cascading information and project status updates.
- Other duties as assigned by client manager.
Preferred Talents
- Excellent communication skills.
- Exceptional interpersonal skills and the ability to collaborate across project teams and workstreams.
- Strong problem-solving capabilities and a proactive approach to overcoming obstacles.
- Animal health background is a strong plus.
Qualifications
- Minimum 5 years of experience in pharma biotech or API manufacturing.
- Minimum 3 years MBR Design experience using Werum PAS-X (version 3.1.8. or later)
- Proven experience (3 years) in FDA regulated manufacturing with electronic batch record design in Werum PAS-X (3.1.8 or later).
- Proven knowledge of FDA and CFR requirements pertaining to batch record design and documentation.
- Proven ability to operate under high-pressure in a timeline constrained environment.
- Ability to travel internationally.
- Pass and maintain pre-employment/contract background check and safety certification including outstanding professional references.
- Successful motor vehicle report review.
- Maintain valid drivers 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 annually.
- Language: English required; French Portuguese and Spanish are advantageous.
Working Environment
While performing the duties of this job the employee must possess the ability to work remote with the ability to travel to client site(s) (<10%).
Employment Type
Full-Time
