Process Engineer - Upstream/Downstream

Integrated Resources Inc.; Harvard (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

A global bio-pharmaceutical company seeks a skilled bioprocessing engineer who will contribute to commercial manufacturing through process monitoring, validation, and technical support. The ideal candidate should have a strong educational background in engineering or biochemistry and relevant experience in bioprocessing, enabling effective cross-functional collaboration.

Qualifications

• Experience in process development and validation for bioprocessing.
• Hands-on experience in chromatography and filtration processes.
• Strong technical writing skills and ability to work in cross-functional teams.

Responsibilities

• Provide technical support for commercial manufacturing processes.
• Conduct troubleshooting and process optimization during scale-up.
• Perform data analysis to ensure product quality outputs.

Skills

Technical documentation

Process troubleshooting

Data analysis

Strong communication

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

Client is a global bio-pharmaceuticalcompany

Job Description

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 Client 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.

Additional Information

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