Senior Process Engineer DSP

Senior Process Engineer Downstream Processing (DSP)

The Senior Process Engineer DSP will have knowledge of manufacturing process parameters and production equipment; they are responsible for making sure that high-quality and efficient production procedures and methods are set up for client’s project.

Department Description

As Senior Process Engineer, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the Downstream Area Lead.

• Create, maintain and review documentation of manufacturing processes, including batch records, PFD, BOM, validation protocols, and SOPs, etc.
• Collaborate with clients to understand Downstream process requirements and incorporate them into the manufacturing processes.
• Take over the role as Function Lead for Client Projects covering the Downstream Unit Operations and the related Buffer preparations.
• Create recipes and design/review single-use assemblies for each process.
• Identify and resolve process-related issues, deviations, and non-conformances in a timely manner. Investigate root causes, propose and implement corrective actions and preventive measures to minimize process disruptions and maintain product quality.
• Contribute to gap/risk assessments and mitigation.
• Participate in projects to implement process improvements, such as implementing automation, lean manufacturing principles, or new technologies.
• May serve as Subject Matter Expert for process and equipment during internal and external regulatory audits (including FDA, EMEA, etc.)
• Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times.
• Where necessary assist in Facility and Equipment start up and Validation activities.
• Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
• Assist as a Production team member, towards delivering production output targets and quality levels on schedule.
• Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures and Manufacturing Batch Records. Perform initial troubleshooting of issues identified during routine operations. Training and mentoring of colleagues in SOPs, process execution and equipment operation.
• Seek opportunities for Continuous Improvement through Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)
• Complete all training in a timely manner and maintained up to date.
• Adhere fully to all safety policies, procedures and regulations
• Ensure highest Quality & Compliance standards

Qualifications

• Master’s degree in biotechnology, biochemistry, engineering or related field. Advanced degree is preferred.

Knowledge/Experience

• Relevant (minim 5 years) work experience within a pharmaceutical manufacturing environment is mandatory.
• Working experience in the CDMO environment is preferred.
• Understanding of technology transfer and scale-up of manufacturing processes.
• Good problem-solving and analytical skills.
• Familiarity with cGMP and regulations is preferred.
• Good interpersonal communication skills and team player mindset.
• Willingness to learn and take on new responsibilities in a dynamic and fast-paced environment
• Fluent in English; German is preferred.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

Would you like to know more before you apply? Please visit us at Biologics is an equal opportunities employer.