Biprocess Engineer

IntegratedResourcesINC

Devens, MA, United States contract

Posted: March 30, 2017

Job Description

Process Engineer Scientific:

• MS&T organization is seeking to fill a Process Engineer position for an 8+ month contract.

• The successful candidate will provide meaningful contributions toward commercial manufacturing support, process monitoring, technology transfer and process validation activities.

• The successful candidate will have a demonstrated background in bioprocessing (upstream and/or downstream), experience troubleshooting manufacturing processes and strong technical documentation skills (memos, protocols, reports).

Responsibilities

• Work independently to provide commercial manufacturing technical support, process monitoring, technology transfer and process validation activities for downstream processes.

• Provide process troubleshooting during scale-up and routine manufacturing. Provide process subject matter expertise and ownership of assigned deliverables.

• The successful candidate will work effectively in highly cross-functional project teams, matrix management environments, as well as independent working environments to support the site.

• Perform data analysis and monitoring for process performance and product quality outputs.

• The position will interface with Manufacturing, Quality, Engineering, and internal MS&T departments at multiple sites throughout the BMS network

• Strong communication and technical writing skills are required.

Qualifications:

• B.S./M.S. or Ph.D. in Chemical Engineer, Biochemical Engineer, Biomedical Engineer, Biochemistry or related field (Advanced degree is preferred)

• Required: Prior experience (Ph.D.: 0 – 2 years; BS/MS: 2 – 6 years) in process development, process validation or manufacturing support in bioprocessing (upstream and/ or downstream)

• Preferred: Prior experience scaling up biopharma manufacturing processes (upstream/downstream), facility fit assessments, process scale-up from bench/ pilot to production, process troubleshooting and optimization, and process validation

• Hands-on experience working with chromatography, ultrafiltration and depth filtration process acquired through lab, pilot or production scale experience.

• Preferred: Experience performing manufacturing investigations for biologics manufacturing.

• Preferred: Experience providing start-up support for new biologics manufacturing processes (Person-In-Plant)

• Preferred: Experience with statistical methodologies (DOE, SPC, etc.), cGMP regulations, and regulatory requirements is expected.

Keywords: Manufacturing Technical Support (MTS), Manufacturing Sciences & Technology (MS&T/MSAT), process validation, PPQ, technology transfer, facility fit, scale-up, process development, bioprocessing

• Prior experience (Ph. D.: 0 – 2 years; BS/MS: 2 – 6 years) in process development, process validation or manufacturing support in bio-processing (upstream and/ or downstream)

All your information will be kept confidential according to EEO guidelines.

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