Sedia Biosciences is hiring a Process Validation Engineer or 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.
FLSA Status: Exempt
Reports to: (Sr) Director/(Sr) VP Operations
- Lead the company’s process validation activities including equipment, cleaning, software, and test methods, (product design 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.
- Process Validation Program: Develop and maintain a Process 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 Study 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.
- Other duties may be assigned by supervisor.
- 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:
- Biochem/lmmunol/Microbiol/Biology/Genetics/Engineering or similar
- Relevant experience in industry: B.S. (6-8+ years), MS (2+ years), PhD (O years)
- Experience in specific responsibilities: 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.
For consideration, please apply with a resume and cover letter. Submitted below under “Apply Now” or by email or U.S. mail.
Submit your resume and cover letter as an attachment in either RTF, Word, or PDF format to firstname.lastname@example.org.
In the Subject Line of your email, enter: “Your last name, your first name, middle initial (middle initial optional), and Job Title (that you are applying for).” For example, “Smith, Mary, Lab Technician.” If you are applying for multiple positions, please submit separate emails for each position.
Submit your resume and cover letter to the address below. On the mailing address outside, send to the attention of HR indicating the position for which you are applying. You may list multiple positions in the attention line. Only one cover letter/resume needs to be sent if you are applying for multiple positions.
Sedia Biosciences Corp.
Attention: HR (List positions you are applying for, separated by commas, here).
9590 Gemini Drive
Beaverton, OR 97008-7166
ABOUT SEDIA BIOSCIENCES
Sedia is a privately held medical device and diagnostics company founded in 2009 and based in Beaverton Oregon. Sedia is committed to the development of novel epidemiological and diagnostic assays and clinical specimen collection products intended to expand access to healthcare worldwide. For additional information, see our website at www.sediabio.com.