Process Equipment Engineer
3 days ago
We are seeking a highly skilled Process Equipment Engineer (Upstream) to join our team. The primary objective of this role is to enable business growth and achieve manufacturing excellence by designing, developing, delivering, maintaining, and improving fixed assets and operational technologies at the best cost while ensuring the highest efficiency.
The Process Equipment Engineer (Upstream) is responsible for ensuring that process equipment procured within the project is fit for purpose and operational.
The scope for Upstream includes the entire process from raw material handling to the production of filled and inspected products, including formulation, filling, and automatic inspection. The goal is to deliver fully functional machine lines from a startup perspective, ensuring seamless transition to the operational owner.
Key Responsibilities:
- Review equipment specifications and establish in-depth process knowledge to support regular manufacturing in a GMP environment.
- Provide process equipment expertise to support the process lead.
- Develop a comprehensive documentation package to ensure a smooth transition to the receiving organization.
- Train and educate operational personnel on the use and maintenance of equipment.
- Establish asset management processes in collaboration with the engineering organization.
- Contribute to the design and implementation of future process and equipment solutions to ensure world-class operations.
- Work in accordance with developed validation plans, qualification test protocols, traceability matrices, reports, and IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols, among other relevant documents.
Qualifications & Experience:
- Extensive experience in pharmaceutical manufacturing.
- Proven experience in process development, improvement, and optimization.
- Strong knowledge of operational environments.
- Hands-on experience with process and production equipment.
- Expertise in technical advanced machines (fully automated), vision systems, infrastructure, and other relevant operational areas.
- Solid understanding of verification and validation processes.
- Familiarity with pharmaceutical and medical device industry regulations, including cGMPs, 21 CFR Part 11, and GAMP5.
Personal Attributes:
- Strong coordination abilities with a structured approach.
- Critical thinker with problem-solving skills.
- Team player with a collaborative mindset.
- Proficiency in English.
If you are passionate about driving excellence in pharmaceutical manufacturing and process engineering, we encourage you to apply for this exciting opportunity.
About agap2
We are part of the European agap2 group, founded in 2005, with a presence in over 14 countries and more than 8,000 employees. Our Swedish office opened in 2017 in Stockholm, and since then, we have collaborated with some of the most innovative companies in the Life Science sector in the Uppsala and Stockholm region.
What we offer you:
- A developing role – A dynamic and challenging position where you have the opportunity to grow both professionally and personally.
- An inclusive work environment – A positive and engaging workplace where your dedication and expertise are valued.
- Collaboration with experts – The chance to work with and learn from industry-leading experts within the Life Science sector.
- A strong sense of community – A workplace that prioritizes team spirit, with regular follow-ups with your consultant manager as well as activities such as events, dinners, and after-work gatherings.
- Benefits that make a difference – A generous benefits package including a collective agreement, competitive salary, extra vacation days, wellness allowance, health insurance, commuter benefits, and much more.
Your application
Send in your CV as soon as possible, as the position may be filled on an ongoing basis.
We look forward to welcoming you to our team and helping you take the next step in Life Science
Do you have questions about the consultant role at agap2?
Seniority level- Mid-Senior level
- Full-time
- Engineering and Consulting
- Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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