Job TitleProcess Engineer - Mfg SupportLocationCambridge,MARequisition Number10911BRJob DescriptionAbout Biogen Idec: Scientific excellence that achieves new standards of care drives the company's work.

Over 20 products are currently in clinical development addressing a variety of key medical needs.In addition to Biogen Idec's promising portfolio of drug candidates, the company's capabilities and capacity for protein manufacturing are world-class in quality and scale.

The company is one of a handful of biotechnology companies that has three licensed and dedicated biological bulk-manufacturing facilities, including its large-scale manufacturing plant in Research Triangle Park, NC, which is one of the world's largest cell culture facilities.

An additional large-scale manufacturing plant is under construction in Hillerod, Denmark.

Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies.

Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as multiple sclerosis (MS), lymphoma and rheumatoid arthritis.

In 2008, Biogen Idec's total revenues surpassed $4 Billion.

The company currently employs approximately 4,700 people worldwide.

+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+Responsible engineer supporting Cambridge commercial and clinical manufacturing.

Lead Operability Reviews during tech transfer of new products into facility and define the necessary modifications and improvements for the campaign.

Specify, procure, and define validation requirements of new equipment, modifications, and projects.

Respond to process and equipment related issues during manufacturing campaigns.

Maintain validated state of equipment by following the defined change control system, specifying required validation activities, and overseeing annual revalidation efforts.

Verify that all equipment and processes are properly configured prior to manufacturing.

Lead multi-disciplined problem solving task teams.

Create and maintain relationships with other sites to develop and promote best practices.

Specify and implement modifications to improve operational performance and compliance.

Manage small capital projects up to $1MM.

Convey necessary information to documentation for the preparation of SOP's and other controlled documents.

Uphold, define, and police safety procedures and safe practices.

QualificationsDirect experience supporting manufacturing in a regulated industry.

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Expertise in equipment design, installation, and start-up.

Trained in formal problem solving techniques.

Demonstrated ability to work in and lead cross-functional teams.

Significant experience creating and executing GMP validations.

Strong computer skills including database, programming, and CAD. Knowledge of control systems and HMI's based on PLC and DCS technologies.

Experience with any/all of the following unit operations or technologies: mammalian cell culture, mixing, CIP, COP, SIP, preventative maintenance, filtration, cross-flow filtration, sterilization, and chromatography.

Education and Experience: BS Chemical or Biochemical Engineering an 10 years industry experience required.

About Biogen Idec: Transforming Discovery into Care With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ: BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology.

Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.

Learn more at www.biogenidec.com/careers .

Biogen Idec is proud to be an equal opportunity employer

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