Downstream Process Engineer - Akka Technologies - BELGIUM

Job description

AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. As part of the development of the activities at one of our clients in the pharma industry, we are looking for a DSP Process Engineer.

The DSP Process Engineer contributes to downstream process tech transfer activities of late-stage and/or commercial biologics to enable launch of these molecules into both internal and external commercial scale facilities. Key responsibilities are:

Supporting Tech Transfer of Downstream Processes (DSP) from Development to Internal Manufacturing and CMOs, and between commercial-scale facilities
Supporting the commercial-scale Process Validations for the Downstream Process in Drug Substance manufacturing
Providing routine (on-the-floor) support during manufacturing campaigns
Providing deviation and investigation support
Supporting Continuous Process Verification (CPV) activities
Supporting Regulatory inspections and filings
Acting as a Subject Matter Expert of late-stage and commercial biologics Downstream manufacturing processes
Acquiring and maintaining process understanding for late-stage and commercial products

The DSP Process Engineer contributes to the timely delivery of the Process Transfer activities.

What are your responsibilities ?

The DSP Process Engineer will:

· Support DSP tech transfer and PPQ activities by contributing to process fit-gap assessments, supportive studies, process validation activities, …

Author technical protocols/reports and ensure a high scientific and quality standard in a timely manner

Perform routine (on-the-floor) support during manufacturing campaigns

Provide deviation and investigation support to Manufacturing

Support CPV and LCM activities, as required

Support Regulatory inspections and submissions

Establish and maintain familiarity with contemporary industrial standards, policies, best practices and technologies

Profile

Who are you ?

Good understanding of Downstream bioprocessing principles (chromatography column steps, ultrafiltration, diafiltration, …)

General understanding of biopharma operations and cGMP

Strong communication skills

Ability to communicate effectively and connect with peers from different functions (matrix organization) to ensure projects are delivered

Good analytical thinking and problem-solving mindset

Familiar with various statistical and data trending techniques

Good technical writing skills

Ability to manage multiple tasks and meet deadlines

Self-motivated, innovation mindset, can-do attitude, team player

Good knowledge of English, both oral and written; knowledge of French is a must.

Offers “Akka Technologies”

Job description