Website Sedia Biosciences Corporation

Sedia Biosciences is hiring a Validation Scientist at our Beaverton, Oregon location. At Sedia, we create diagnostic and disease-monitoring products that provide cost effective solutions for rapid, near patient testing. We are currently seeking responsible individuals motivated to help research and develop our future diagnostic products.

Position Summary
FLSA Status:   Exempt

Reports to:  (Sr) Director/(Sr) VP Operations

Lead the company’s validation activities including equipment, Process, cleaning, software, and test methods, (product validation not included).
Collaborates with colleagues across all departments to develop and execute validation protocols based on risks associated with the subject of the validation exercise.
Primary Responsibilities

Qualification and Validation Program; develop and maintain a Validation Program along with supporting documentation to reduce and or eliminate the risk to the quality, safety, and efficacy of the product impacted by the subject of a given validation.
Validation Assessment and Protocols: fully understand and document the subject of validation and then translate that into and effective validation protocol to be executed which mitigates any risk to an acceptable level
Validation Design; develop robust protocols using sound scientific methods and statistical means that fully interrogate the subject of validation and which can stand up to critical review by independent auditors
Provide critical feedback to R&D and Project Manager on product/process claims to ensure they can be properly validated.
Assist R&D in developing product/process methods and data that support downstream production, qualification, and validation efforts..
Create metrics/key performance indicators and maintain to proactively manage the validation program.
Equipment Management; conducts and maintains new and existing equipment assessments and ensure qualification and maintenance of equipment and tools in order to consistently manufacture, test and store Sedia’s products.
Assist with Facilities Management – may be required to contribute to facility design and maintenance to ensure it is designed, built, commissioned, and maintained to meet requirements and controls to manufacture, test and store Sedia’s products.
Supervisory Responsibilities

May be required to supervise a small team
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Degree(s)/Fields: B.S., MS or PhD in:
Relevant Experience in Industry: Biochem/Immunol/Microbiol/Biology/Genetics/or similar
Experience in specific Responsibilities: B.S. (6-8+ years), MS (2+), PhD (0); years in
Must have prior relevant laboratory experience. Experience working in the medical device or pharma arena under a quality system such as ISO 13485 and or CFR 21 part 820 cGMPs or GLP is preferred.
Supervisory Experience: Not required.

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