Process Validation Scientist

1 month ago


Søborg, Denmark AGC Biologics Full time

Copenhagen, Denmark

Are you ready to employ your knowledge and experience in order to improve patients’ lives? Would you like to play a crucial role in ensuring adequate process validation strategy is applied in biopharmaceutical manufacturing? If yes, welcome. You are on the right page

We, Process Validation Department, work with portfolio of diverse projects to provide necessary knowledge and documentation to our customers and support their journey through all phases of a process validation. We work with trust, knowledge, ingenuity, accountability and team spirit sprinkled with good sense of humor and laidback atmosphere.

What you can expect in a Process Validation Scientist role in AGC Biologics:

  • Lead, coordinate and oversee validation activities for drug substance manufacturing throughout the process validation lifecycle.
  • Prepare risk assessments (extractable and leachables, nitrosamine, elemental impurities)
  • Write process mix and hold validation plans, protocols and reports in a timely manner and according to project requirements.
  • Be responsible for CPV program for our commercial projects.
  • Use scientific knowledge to analyze and interpret data. Take timely and appropriate action based on the data output, project needs and internal procedures.
  • You will represent our department effectively and professionally in interactions with internal and external stakeholders.
  • Represent the department in audits and regulatory inspections.
  • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory guidelines.
  • Assess impacts on validated processes and propose mitigating actions, if required.

You:

  • Degree in biological sciences, pharmacy, engineering, or related fields.
  • At least 1 year of relevant experience in process validation.
  • Familiar with cGMP, EMA, FDA, and ICH guidelines for process validation.
  • At least 2 years of relevant experience in upstream and downstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting.
  • A fast learner, proactive professional, with positive mindset to work with multidisciplinary teams and find solutions to challenges.
  • Able to work independently toward defined goal.
  • Strong technical writing and presentation skills.
  • Experience with SAS JMP and data handling is advantage.

The company language is English, so adequate written and spoken English communication skills are required.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


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