Biprocess Engineer

Integrated Resources Inc.; Harvard (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in biopharmaceuticals is looking for a Process Engineer for an 8+ month contract. The role involves providing technical support in manufacturing processes, troubleshooting, and ensuring process validation. Candidates should have a solid background in bioprocessing and effective communication skills, working within cross-functional teams for operational success.

Qualifications

• Prior experience (Ph.D.: 0 – 2 years; BS/MS: 2 – 6 years) in bio-processing.
• Experience troubleshooting manufacturing processes.
• Hands-on experience working with biopharmaceutical manufacturing.

Responsibilities

• Provide commercial manufacturing technical support for downstream processes.
• Perform data analysis and monitoring for process performance and product quality.
• Interface with multiple departments to support manufacturing operations.

Skills

Technical documentation

Communication

Data analysis

Education

B.S./M.S. or Ph.D. in Chemical Engineering

B.S./M.S. or Ph.D. in Biochemical Engineering

B.S./M.S. or Ph.D. in Biomedical Engineering

B.S./M.S. or Ph.D. in Biochemistry

Tools

Chromatography

Ultrafiltration

Depth filtration

Job description

• 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

Qualifications

• 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)

Additional Information

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