Process Validation Engineer (Pharma/Medical Device)

Job Title:

Senior Operations Scientist Location:

Scarborough, Maine Work Type:

Onsite Schedule:

Monday to Friday, 40 hours per week (overtime available)

Contract Duration:

6 months (possibility of extension)

Pay:

Competitive, based on experience Overview This role focuses on process validation, data analysis, and execution of scientific studies within a regulated environment. The ideal candidate will have strong experience in validation activities, data interpretation, and hands-on laboratory work. This position requires collaboration with cross-functional teams including R&D, Quality Assurance, and Manufacturing. Key Responsibilities Develop validation protocols and reports for manufacturing processes, including operational qualification, performance qualification, and process validation Execute validation activities related to reagent manufacturing processes such as mixing, pooling, and solution preparation Design and conduct experiments, including Design of Experiments (DOE), to evaluate process conditions and performance Collect, analyze, and interpret manufacturing data to identify trends and support process improvements Create data tracking tools and dashboards to summarize results and support decision-making Prepare and maintain technical documentation including SOPs, study protocols, and reports in compliance with quality systems Ensure adherence to Good Manufacturing Practices and quality standards Collaborate with cross-functional teams to support process development and continuous improvement initiatives Required Qualifications Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific field Minimum 6 years of experience in a scientific, manufacturing, or operations environment Experience with process validation, including operational qualification and performance qualification Strong data analysis skills with experience using tools such as Minitab or JMP Ability to design, execute, and interpret scientific studies Hands-on laboratory experience and understanding of best practices for handling reagents and preventing contamination Strong written and verbal communication skills Preferred Qualifications Master's or PhD in a scientific or technical discipline Experience in diagnostics, immunoassays, or reagent manufacturing Experience with data visualization and data management tools Familiarity with project management tools such as

Smartsheet or Microsoft Project Pay:

$45.00 - $47.00 per hour Expected hours: 40.0 per week

Benefits:

Health insurance

Education:

Bachelor's (Preferred)

Experience:

operational qualification and performance qualification: 6 years (Preferred) Design of Experiments (DOE): 6 years (Preferred)

Process Validation:

6 years (Preferred) Validation - key skill.

Operations Qualifications:

6 years (Preferred) test method validation (TMV): 6 years (Preferred)

IQ/OQ/PQ

6 years (Preferred) Ability to

Commute:

Scarborough, ME 04074 (Preferred)

Work Location:

In person