Process Engineer DSP

Responsibilities

• As a Pharma Process Engineer, you’ll be at the heart of our operations, maintaining and improving production processes while leading supportive processes to ensure continuous improvement.
• You’ll work closely with management and operations to drive decisions regarding process engineering and methods, aiming to produce comprehensive processes, operational efficiencies, and alignment with production goals.
• Your effective communication skills will be key as you interact with both internal and external customers.
• Your expertise will be essential in implementing Operations unit objectives, such as the introduction of new production processes and systems, and ensuring the smooth operation of existing processes.
• You’ll supervise and continuously assess the process to ensure it operates within validated and regulatory limits, achieving expected output/yield, and collaborate with multi-functionally teams to develop strategies and implement improvements to minimize downtime and losses.
• You’ll lead the management of data collection, analysis, and reporting to drive continuous process improvement, ensuring compliant documentation and accurate completion of process records.
• You’ll initiate, drive, and lead process improvements in collaboration with partners, and support formal issue processes to highlight risks related to safety, product quality, and regulatory compliance.
• You’ll be the go-to guide for sophisticated Product Impact Assessments and Change Control designs, from initiation to completion.
• You’ll conduct Gemba walks to view the process performed by the manufacturing operators and lead sustainable improvements to enhance safety, quality, reliability, cost, and scheduling.
• You’ll engage in Continuous Process Verification (CPV) activities by providing information and performing additional research.

Requirements

• A relevant University degree or equivalent experience 
• Dutch A2 and English C1 language levels are required.
• 4-8 years experience in pharma sector as Process Engineer or Bioprocess Engineer
• DSP operations process engineering experience (Downstream Processing Expertise)
• Has participated in at least one NPI or site transfer project (from development > manufacturing)
• Strong in GMP, DSP unit operations, process validation, and tech transfer
• Comfortable working on site 3–4 days/week in a regulated pharma plant
• Looking for someone asap, 1 year assignment, option for extension.