Full-Time

Quality Assurance Validation Engineer

Updated on 12/5/2024

Serán BioScience

Serán BioScience

51-200 employees

Contract development and manufacturing for pharmaceuticals

Biotechnology
Healthcare

Mid

Bend, OR, USA

This position requires onsite presence in Bend, Oregon.

Category
QA & Testing
Manual Testing
Quality Assurance
Requirements
  • Comprehension of current regulations and guidelines (e.g., 21 CFR Part 11, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort
  • Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
  • Hands-on experience with a minimum of two of the following: qualification of facilities, utilities, equipment and/or cleaning or process validation
  • Experience performing cleaning and/or process validation is preferred
  • Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
  • Experience performing equipment qualification for OSD systems is required
  • Strong time-management skills and the ability to organize and coordinate multiple projects at a time
  • Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
  • Bachelor’s degree in science, engineering, or related field with 3-5 years of experience in the pharmaceutical industry
  • Minimum of three years of experience performing qualifications and/or validations
Responsibilities
  • Generates and/or supports the generation of risk assessments, user requirements specifications (URS), validation plans, change requests, SOPs, CAPAs, and other relevant documents
  • Supports validation lifecycle activities to ensure that qualified systems remain in their validated state
  • Supports the qualification/validation effort driven by the MSAT group, including qualification of OSD systems, process validation, and cleaning validation
  • Provides support during clients and regulatory audits
  • Other related duties as assigned

Serán Bioscience specializes in providing drug development and manufacturing services as a Contract Development and Manufacturing Organization (CDMO). They offer a variety of services, including preformulation, formulation development, dosage form development, spray drying, and particle engineering. Their operations adhere to current Good Manufacturing Practice (cGMP) standards, ensuring high quality and safety in their products through rigorous analytical quality control. Serán Bioscience serves a wide range of clients, from small biotech startups to large pharmaceutical companies, and is distinguished by its flexibility in tailoring services to meet specific client needs. The company's goal is to enhance the efficiency and effectiveness of drug development processes for their clients, ultimately leading to successful outcomes.

Company Stage

Growth Equity (Venture Capital)

Total Funding

$194.5M

Headquarters

Bend, Oregon

Founded

2016

Growth & Insights
Headcount

6 month growth

83%

1 year growth

83%

2 year growth

83%
Simplify Jobs

Simplify's Take

What believers are saying

  • Expansion of cGMP manufacturing capacity at the Bend site indicates growth and increased service capabilities.
  • Partnership with Oregon Bioscience Association to establish an apprenticeship program highlights Serán's commitment to workforce development and community engagement.
  • Serán's expertise in advanced drug formulation techniques can attract a diverse range of clients, from small biotech startups to large pharmaceutical corporations.

What critics are saying

  • The highly competitive nature of the pharmaceutical and biotechnology markets requires continuous innovation to stay ahead.
  • Dependence on pharmaceutical companies for revenue means that any downturn in the pharma sector could impact Serán's business.

What makes Serán BioScience unique

  • Serán Bioscience's focus on advanced drug formulation techniques like spray drying and particle engineering sets it apart from other CDMOs.
  • Their flexibility in tailoring services to meet specific client needs ensures successful outcomes, a competitive advantage in the pharmaceutical industry.
  • The company's commitment to cGMP manufacturing and analytical quality control guarantees high standards of quality and safety, which is crucial in the pharmaceutical sector.

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