Process Engineer​/scientist

Artech Information System , a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients and we currently have a job opening that may interest you.

1.

Job Title:

Process Engineer

Job
-1

Duration: 8+ month with potential for extension

Process Engineer

The Client Devens, MA 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).

• 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.

• B.S./M.S. or Ph.D. in Chemical Engineer, Biochemical Engineer, Biomedical Engineer, Biochemistry or related field (Advanced degree is preferred)
• 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)
• 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.
• Experience performing manufacturing investigations for biologics manufacturing.
• Experience providing start‑up support for new biologics manufacturing processes (Person‑In‑Plant)
• 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

2. Position:
Process Engineer

Job
-1

Duration: 6 Months with potential for extension

Required Skills:

LARGE SCALE CELL HARVEST EXPERIENCE NEEDED

UPSTREAM

KNOWLEDGE OF CELL CULTURE BUT WILL NOT BE WORKING ON IT

WILL BE TROUBLESHOOTING-FIRST LINE TECHNICAL SUPPORT FOR CELL CULTURE.

LOT OF DATA AND STATISTICAL ANALYSIS AND DATA INTERPRETATION

• Serve as a process technical expert to large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals s position offers the opportunity to resolve complex problems while meeting quality, schedule, and cost objectives. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will set appropriate objectives and priorities, overcome obstacles;

and deliver results within project timelines.

• Expertise and experience in one or several aspects of the design, control, and operation of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations are highly desired

• Demonstrated skills in cross‑functional partnerships, supporting cross functional teams and knowledge of regulatory and cGMP requirements are required.

• Supports the preparation of CMC documentation for…