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Senior Validation Engineer Woburn United States,  

Amgen (company)

Posted on : 26 September 2017

Project Description

Amgen Woburn is the approved facility for the manufacturing of a viral oncolytic therapy. The Senior Validation Engineer will be responsible for leading the Validation Program. The position reports into the Director of Manufacturing. This role will be a key interface between Validation, Manufacturing, Quality, F&E and Supply Chain and will drive the validation efforts to maintain the site in a compliant state.

Complete understanding of validation operating standards and procedures
Lead validation program and support the execution of projects, investigations, and/or troubleshooting.
Support the development of the validation execution strategy with project teams for Computer, Equipment and Cleaning Validation
Responsible for interactions with Amgen s Corporate Validation network, offer advice on strategic management of the validation program and present their work during audits and regulatory inspections.
Structure engineering/characterization studies that integrate cross-disciplinary and cross-functional issues to arrive at optimal course of action
Establish networks and act as the liaison between corporate and site initiatives along with leading benchmarking activities and continuous improvement efforts
Responsible for Good Documentation Practices
Participate and help lead cross-functional teams

Basic Qualifications:
Doctorate degree OR
Master s degree and 3 years of Engineering and/or Validation experience OR
Bachelor s degree and 5 years of Engineering and/or Validation experience OR
Associate s degree and 10 years of Engineering and/or Validation experience OR
High school diploma / GED and 12 years of Engineering and/or Validation experience

Preferred Qualifications:
Skilled in performance of GMP production operations
Advanced scientific and engineering knowledge
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
Organizational, technical writing and presentation skills
Good project management skills
Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
Ability to recommend, judge, and make good decisions in complex situations
Takes decisions that maximizes benefits and minimizes risks, achieving sustainable results

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.

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.


US, Massachusetts, Woburn

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