Details for the position are as follows:
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- Rate:$45-49 an hour
- 6-month contract to start with the possibility of extension or conversion depending on performance and business needs
- Location: Scarborough, ME – 100% onsite – open to candidates willing to relocate at their own expense
- Draft validation protocols, execute validations, and draft validation reports for reagents manufacturing processes (i.e. mixing, pooling, cleaning) – operational qualification (OQ), test method validation (TMV), performance qualification (PQ), and process validation (PV) are all within scope
- Design of Experiments (DOE) involving different reagent combinations, concentrations, and operating conditions – coordinating execution, documenting results, and presenting findings
- Develop and maintain data tracking sheets for experiment results, critical process parameter (CPP) operating ranges, critical quality attribute (CQA) results across manufacturing events
- Utilize quality management system (QMS) for documentation of study results, complying to site design control and validation procedures
- Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, risk assessments, and procedures and other technical documents to insure compliant, efficient and safe processes.
- Use design for manufacturability (DFM) principles to make recommendations for design improvements
- Work cross-functionally with R&D and QA to develop study plans and execute process & design improvements
- Bachelor’s degree (BS) in Biology, Chemistry, Engineering or similar scientific/technical discipline
- 6+ years of experience in a scientific/technical role in Operations or R&D
- Proficient with statistical analysis software (Minitab or JMP preferred)
- Exposure to diagnostics and immunoassay technologies
- Experience with data science/data visualization highly preferred
- Familiarity with basic project management tools and principles (i.e. Smartsheet, Microsoft Project)
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy