18 days old

Validation Engineer

Woburn, MA 01801
  • Job Code

Job ID: R-101236
Location: Woburn, MA, US 01806

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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement attitude, and an unyielding focus on safety, quality, and compliance.

This role of Validation Engineer for AWM reports directly to the Validation Lead. The Validation Engineer will perform validation support for a variety of equipment to support drug substance and drug product manufacturing operations.

Responsibilities include, but are not limited to the following:

  • Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.
  • Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.
  • Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
  • Perform IQ, OQ, PQ validation on processes, equipment and systems in conjunction with suppliers as appropriate.
  • Monitor trial, engineering and validation batches to ensure appropriate conditions are met and required samples are taken.
  • Co-ordinate delivery of samples to the laboratories and co-ordinate testing of same
  • Co-ordinate shipment of samples, if required
  • Co-ordinate the individual tasks required to validate processes equipment etc.
  • Participate, when required, as a member of multidisciplinary site teams, e.g. Cross Functional Investigation Team.
  • Write, review and update Standard Operating Procedures (SOP's) in accordance with site and corporate requirements.
  • Use specified software packages (e.g. Word, Excel, DMS, Datatrace, Kaye etc.).
  • Compile and maintain all relevant documentation for submission to management (protocols and reports).
  • Attend and contribute to staff meetings and attend appropriate training sessions, as required.
  • Comply with the responsibilities as outlined in the Site Safety Statement
  • Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen's requirements, policies and procedures.
  • Champion safe working practices and safety initiatives within their functional area
  • This is an Administrative Shift position

Basic Qualifications:

  • Master's degree
  • OR
  • Bachelor's degree and 2 years of Quality, Validation, Manufacturing and/or Operations experience
  • OR
  • Associate's degree and 6 years of Quality, Validation, Manufacturing and/or Operations experience
  • OR
  • High school diploma / GED and 8 years of Quality, Validation, Manufacturing and/or Operations experience

Preferred Qualifications:

  • Quality and/or Validation experience
  • Mechanical ability/expertise
  • Strong understanding of biomanufacturing equipment and processes
  • Basic statistical mathematical skills
  • Ability to interpret and apply GMP knowledge
  • Understanding of analytical methods for the manufacturing area
  • Ability to demonstrate technical writing capability
  • Able to demonstrate project management skills and presentation skills
  • Independently collaborate with outside resources
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Strong analytical and experimental design skills
  • Strong troubleshooting and problem-solving skills
  • Experience with automation systems
  • Demonstrated ability to lead teams
  • Experience with Lean Manufacturing Principles

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.



Posted: 2020-07-18 Expires: 2020-08-18

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Validation Engineer

Woburn, MA 01801

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