26 days old

Sr Validation Engineer

Amgen
Woburn, MA 01801
  • Job Code
    121696702
Amgen

Job ID: R-101234
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.

The Sr Validation Engineer position presents an opportunity for the candidate to merge leadership skills, technical knowledge of the operation, and general project management skills in support of Operational Excellence (OE).

Responsibilities include, but are not limited to the following:

General:
  • Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial and Syringe Filling.
  • Leading the team to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training.
  • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
  • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
  • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
  • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS's), Factory Acceptance Tests (Fat's) to ensure the QBD principles are being followed.
  • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
  • Collate and report on relevant Validation data/matrices.
  • Assist in deviation and exception resolution and root cause analysis.
  • Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
  • Participate as required in project activities.
  • Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.
  • Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment.
  • Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
  • Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.
  • This is an Administrative Shift position


Basic Qualifications:

  • Doctorate degree


Or

  • Master's degree and 3 years of Quality, Validation, Manufacturing and/or Operations experience


Or

  • Bachelor's degree and 5 years of Quality, Validation, Manufacturing and/or Operations experience


Or

  • Associate's degree and 10 years of Quality, Validation, Manufacturing and/or Operations experience


Or

  • High school diploma / GED and 12 years of Quality, Validation, Manufacturing and/or Operations experience


Preferred Qualifications:

  • Quality and/or Validation experience
  • Experience interacting with representatives of regulatory agencies
  • Experience and solid understanding of quality systems including change control process
  • Familiarity with 21 CFR Part 11 and basic concepts of Data Integrity
  • A comprehensive understanding of regulatory requirements and their applications in GMP environment
  • Experience participating in and helping to lead cross-functional teams
  • Experience in leading multiple, contending priorities in a fast-paced environment
  • Strong technical writing and presentation skills
  • Project management experience
  • Detailed technical understanding of bioprocessing unit operations
  • Skilled in performance of GMP production operations
  • Ability to communicate and collaborate with technical and management staff


Competencies:

  • Passion for Operational Excellence
  • Communications skills, both oral and written, including presentation skills
  • Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met
  • Ability to tactfully negotiate and positively influence peers and executive leadership
  • Analytical skills to identify potential improvement opportunities


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.



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

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Sr Validation Engineer

Amgen
Woburn, MA 01801

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