Senior Process Engineer DSP

Wuppertal - Germany

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

Senior Process Engineer Downstream Processing (DSP)

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

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 clients 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.

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities:

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

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications:

Masters 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 .
WuXi Biologics is an equal opportunities employer.

Required Experience:

Senior IC

Senior Process Engineer Downstream Processing (DSP)Teil II Primäres Ziel der Stelle / Part II Primary Job ObjectiveThe 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 pr...

Senior Process Engineer Downstream Processing (DSP)

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

Department Description

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities:

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

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications:

Masters 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 .
WuXi Biologics is an equal opportunities employer.

Required Experience:

Senior IC

Key Skills

Arm
Python
Debugging
C/C++
5G
Signal Processing
Matlab
Fpga
Linux
Software Development
Assembly
4G/LTE

Apply Now

About Company

WuXi Biologics

A leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing

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