MES Author

Location: Malvern

About Us

For 75 years, Fujirebio Diagnostics Inc., is a leading worldwide biotechnology Company and the innovation engine behind diagnostic breakthroughs that reach patients worldwide. Our in vitro diagnostics (IVD) technology powers critical tests across the globe's leading diagnostic platforms. We are a biomarker and diagnostic content provider that strengthens diagnostics for everyone. Through our approach of innovation, clinical evidence and global CDMO partnerships, we ensure that next-generation biomarkers are accessible across diagnostic platforms, so patients benefit no matter which system is used.

Position Summary: This position is responsible for the development and maintenance of MES recipes and worksheets to replace paper batch records of laboratory activities in a diagnostic environment. Laboratories include, but are not limited to, the following:
Buffer Preparation, Antibody Purification, EIA, Cell Culture, Microparticle, IQA, QC, Microbiology, Calibrator, Filling and Labeling/Packaging.

The ideal candidate will have an information technology background and experience with software development, including proficiency in one or more programming languages (e.g., C#, Python, Java, C++, SQL). Experience in a life sciences manufacturing environment is preferred but not required.

Essential Job Functions:

• Executes peer reviews as required
• Generates inventory for testing requirements through recipe development and validation
• Generates process flows for MES recipe development as needed
• Authors MES recipes and worksheets with external/internal resources to ensure timelines are met
• Maintains existing MES recipes and processes change requests through MES Change Control Process
• Interacts with Subject Matter Experts to accurately capture departmental procedures during E  authoring
• Executes MES recipe validation (OQ, PQ)
• Responsible for Oracle Formula generation in parallel with change management
• Cross trained to act as a backup for MES Support
• Executes qualification documentation for MES recipe change control
• Responsible for demonstrations of applicable MES recipes
• Assists MES Analyst for MES Change Control, including updating justification and providing objective evidence as required
• Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner
• Performs other duties as assigned

Job Specifications (skills, knowledge, special training, certification, license requirements):

• Strong understanding of biology, immunoassays, antibodies
• Good understanding of cGMP quality and regulatory standards maintained in industry (S88, S95, GAMP, 21 CFR Part 11)
• Experience with workflow builder and conditional branching
• Interpersonal skills and the ability to interact with various levels of personnel
• Excellent organizational skills and attention to detail
• Excellent attendance and the ability to work overtime, as needed

Education and Work Experience Required:

• B.S. degree in Information Technology (Computer Science), Computer System Engineering, Life Sciences or related field
• Minimum of 2 years of industry-related experience
• MES development experience preferred (Werum PAS-X, Rockwell, POMSnet, Oracle)
• Coding (C#, VSB) experience preferred

The base salary range for this position is $64,000- $70,000/year. The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. The typical work schedule for this position is Monday to Thursday with half-day Fridays.

We offer a competitive benefits package that starts on day one, including three medical plans, savings and spending accounts, employer-paid dental & vision, 401(k) match up to 6%, life insurance and disability, educational assistance, EAP, generous Paid Time-Off, paid holidays, and opportunity for advancement.

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer