Process Engineer/ Scientist

Job Description

1.Job Title: Process Engineer

Job ID: 21253-1

Location: Devens, MA- 01434

Duration: 8+ monthwith 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).

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

2.Position: Process Engineer

Job ID: 21337-1

Duration: 6 Months with potential for extension

Location: Devens, Massachusetts-01434

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 INTERPRATION

Job Description:

·Serve as a process technical expert to large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals at Devens. This 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.

Responsibilities:

·Supports the preparation of CMC documentation for regulatory filings and responses for the Client-Devens commercial

·Ability to analyze large data sets using advanced statistical and modelling methods to drive solutions in a fast paced environment.

·Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls.

·Supports commercial manufacturing via in-plant coverage and real-time process upset troubleshooting.

·Evaluates process performance through statistical analysis with recommendations generated for process enhancement.

·Supports upstream aspects of process technology transfer and process validation through individual technical contribution.

Qualifications:

BS or equivalent with 2-4 years relevant experience, MS or equivalent with 2 years relevant experience.

Proficiency of SOPs, cGMPs and the know how to work and manage within a regulatory environment.

Experience in successful execution and management of process technical transfer.

Experience in designing and executing process and equipment validation plans.

Experience in the design, modification and optimization of biologics cell culture unit operations•.

Experience in investigating process deviations and developing issue resolving CAPAs.

Proven project management skills and effectively balancing project assignments with other duties.

Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.

Excellent verbal & written communications skills.

Principal assignment is in a modern LSCC building which requires adherence to various Personal Protective Equipment (PPE) standards.

Thanks 

Sanjay

973-295-4593

Qualifications

Additional Information

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