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Sr Validation Engineer

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Senior (5-10 years)
Work from: 
Ireland, United States

Offer summary

Qualifications:

Bachelor's degree in Engineering or related field, Experience in process validation and quality oversight, Knowledge of regulatory requirements, Strong understanding of aseptic processing.

Key responsabilities:

  • Oversee process and cleaning validation activities
  • Prepare and review validation documents
AMGEN logo
AMGEN Biotech: Biology + Technology Large http://www.amgen.com
10001 Employees
About AMGEN
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. See our Community Guidelines: bit.ly/smcgl Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
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Job description

Career Category
Quality
Job Description

Description

The Senior Validation Engineer will work remotely and report to the External Supply Quality Validation Pod lead, located in the US.  The selected candidate will oversee strategies and documents related to process, cleaning, filter and sterilization/sanitization validation activities at contract manufacturing organizations (CMOs) located across North America and Europe.  CMOs will range across synthetics, small molecules and large molecule products at API, DS, DP and FDP manufacturing sites.

Key Responsibilities

  • Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc.  Project teams will include: tech transfers, new product introductions, and ongoing validation maintenance activities.
  • Translate Amgen requirements into the language of the CMO
  • Identify and assess validation/quality risks to enable risk-based decisions
  • Validation document author/approver
  • Aseptic processing system oversight (media fill, autoclave validation, EM)
  • Prepare materials/documents (playbooks) for topics to be presented during audits/inspections
  • Perform validation change control assessments
  • Review/approve validation deviations
  • Review/approve Master Batch Records
  • Perform Person in Plant activities as required
  • Escalate issues to Validation/Quality management, as needed
  • Write/review responses to regulatory questions (RTQs)
  • Drive Operational Excellence and Champion Change

Authority

  • Determine outcome of validation activities
  • Decision to approve or reject validation documentation
  • Provide input on Validation position on related topics and strategy for the site
  • Decision to approve Master batch Records

.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Risk AnalysisAseptic ProcessingRegulatory ComplianceVerification And ValidationValidation ProtocolsChange ControlQuality ManagementAudit Report Preparation

Other Skills

  • Teamwork
  • Communication
  • Problem Solving
Are you interested?

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