The Process Engineering Department is looking for an experienced Process Engineer to assist AGC Biologics in our continuous growth. You will become part of an agile and newly established department of highly dedicated scientists and technicians that work closely with external customers and internal stakeholders.
Suppose you have a strong compliance mindset and would like to work with cGMP in relation to a variety of different biopharmaceutical manufacturing processing equipment. In that case, this position is something for you. You will cooperate closely with the other departments at AGC Biologics in CPH and with colleagues from our sister sites in the US, Japan, and Germany to ensure that all quality-related activities are carried out LEAN effectively and in compliance cGMP. The Process Engineering team has a positive and proactive profile is committed, professional and friendly collaboration.
Therefore, your main tasks will be to:
- Managing manufacturing process improvements/changes requiring cross-functional oversight
- Ownership of equipment modules and packages through design and procurement phases
- Develops implementation cost models for project development and implementation.
- Collaborating with key departments and personnel in technology transfer projects
- Supporting implementation of new processes in manufacturing operations.
- Leading or assisting implementation of new manufacturing equipment to enable transition from early clinical trials to late stage and commercial GMP processes
- Optimizing processes and procedures to collaboratively create manufacturing efficiency, process robustness, reduced costs and facility reliability
- Leading cross-functional collaborations to meet project timelines requirements.
- Conduct process FMEA sessions during Design & Pilot phases.
We imagine that you have:
- A scientific education (BSc or MSc) in Engineering, Bioprocessing, Biology or related discipline is required.
- At least five years of working experience with cGMP, FDA regulations and Occupational Safety and Health Administration (OSHA) rules with knowledge of documentation systems (i.e., BPRs, Validation Protocols, Standard Operating Procedures (SOPs), expense budget, work orders, purchasing systems) of a business in the biopharmaceutical industry;
- A holistic understanding of manufacturing processes and facilities for cGMP manufacturing of biological intermediates and APIs for mammalian and microbial bulk production processes,
- Demonstrate a high level of initiative in troubleshooting and accurate data analysis.
- Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
- The ability to balance many tasks simultaneously
- Excellent collaboration skills
- Experience with LEAN manufacturing
- Basic knowledge of PI systems Experience, MES and EBR
- Strong English communication skills (AGC's language is English)
In addition, you must thrive in a dynamic and fast-paced working environment where changes occur on short notice. The environment is dynamic and challenging at times, which requires finding solutions, delivering on promises, and giving our customers a positive experience.
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.