Process Engineer – Technical Operations Biotech

2 maanden geleden

Oss, Nederland MSD Voltijd

Job Description

We are seeking a highly skilled and experienced Process Engineer to join our team in the pharma industry. As a Process Engineer, you will provide process technological support to our local cell culture and purification facilities, while also being involved in 2nd line troubleshooting, process improvement projects, and new product introductions.

For our location in Oss we are looking for a Process Engineer.

Welcome to our team:

CoE (Centre of Excellence) Biotech Technical Operations in Oss provides process technological support to the local cell culture and purification facilities and involves 2nd line trouble shooting, process improvement projects and new product introductions. The work in BTO is highly multidisciplinary as it requires close collaboration with manufacturing operations (IPT), analytical laboratories, quality assurance, regulatory affairs and global technical groups. The team consists of approximately 50 members, with expertise in a variety of topics like microbiology, cell culture, purification, engineering, small-scale laboratory operations and process and system validation.

The role:

As a Process Engineer in the pharma industry, your role will be critical in providing process technological support to our local cell culture and purification facilities. You will be responsible for various aspects including 2nd line troubleshooting, process improvement projects, and new product introductions.

Your primary responsibility will be to ensure that the systems used in the pharmaceutical production of biologics are compliant with GMP regulations. This will involve supporting upstream and downstream manufacturing and providing expertise in (capital) projects on system design and execution. You will also be responsible for evaluating equipment user requirement specifications and conducting process and facility fit assessments.

In this role, you will review engineering proposals and protocols, ensuring that sound engineering principles are applied and that the proposals are compliant with EHS/GMP requirements. You will collaborate closely with different departments such as manufacturing operations (IPT), analytical laboratories, quality assurance, regulatory affairs, and global technical groups.

Your strong analytical and systematic problem-solving skills will be crucial in supporting investigation teams to identify the root cause of system failures and implement corrective/preventive actions. Your ability to present persuasively, based on your expertise and "science-based" arguments, will also be essential.

Additionally, you will be expected to actively contribute to cross-functional projects and monitor the work/design of internal and external partners to ensure successful project delivery. While working in a team of approximately 50 members, you will collaborate in a multidisciplinary setting, leveraging expertise in topics such as microbiology, cell culture, purification, engineering, small-scale laboratory operations, and process and system validation.

Your commitment to safety, quality, and adherence to guidelines will be vital. You should also have a customer-focused, process-oriented, and data-driven approach. Experience with lean problem-solving methodologies and a basic understanding of CGMP guidelines and regulatory expectations are highly desirable.

Your profile:

Bachelor’s degree in life sciences or equivalent experience. 1-4 years of experience in (biologics) pharmaceutical manufacturing. Engineering knowledge of pharmaceutical equipment and production/purification processes Ability to work in a multidisciplinary setting and contribute to cross-functional projects Strong analytical and problem-solving skills Understanding of CGMP guidelines and regulatory expectations Strong communication skills in Dutch (preferred) and English, both verbal and written.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

Competitive salary and a 3% year-end bonus; 35,5 days of leave; Attractive collective health care insurance package; Solid Pension Plan; •Incentive Plan;

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