Full-Time

Quality Assurance Validation Engineer

Confirmed live in the last 24 hours

Serán BioScience

Serán BioScience

51-200 employees

Contract development and manufacturing for pharmaceuticals

Biotechnology
Healthcare

Mid, Senior

Bend, OR, USA

This position requires onsite presence in Bend, Oregon.

Category
QA & 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.

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

  • Serán's $200M expansion includes a new commercial-scale manufacturing facility.
  • Increased demand for personalized medicine boosts growth in the CDMO sector.
  • Advancements in particle engineering enhance drug delivery systems, benefiting Serán's offerings.

What critics are saying

  • Emerging CDMOs in Asia offer lower-cost services, increasing competition.
  • Potential U.S. regulatory changes on drug pricing may impact Serán's client revenue.
  • Talent shortages in biotech could hinder Serán's planned workforce expansion.

What makes Serán BioScience unique

  • Serán BioScience specializes in advanced drug formulation and particle engineering techniques.
  • The company offers flexible, tailored services to meet specific client needs.
  • Serán's commitment to cGMP manufacturing ensures high-quality and safe pharmaceutical products.

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