Orion Group Life Sciences are looking for a Senior Associate Manufacturing for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with high possibility of extension. This is a hybrid position, where you have to be 2-3 times per week onsite.
What will you do
The Operations Improvement Team (OIT) is responsible for the design of all packaging processes within the Manufacturing area at our client in Breda. These processes vary from an almost completely manual process to an almost fully automated packaging line.
The OIT team identifies opportunities for improvement through line observations and data analysis and investigates the major process deviations and complaints.
Investigation and implementation activities are always guided by defined processes and systems (CAPA/Change Control/Document Management). Everything is aimed at assuring the quality of the output of the packaging process. All processes are captured in written procedures.
Main Responsibilities of the role
Work within full GMP compliance.
Investigate unforeseen deviations related to the packaging processes to find root causes.
Host cross-functional meetings to retrieve and discuss the input needed for the investigation.
Create well-documented reports (written in English) of the investigations and the Root Cause Analysis according to our clients' standards.
Define and implement solutions to prevent reoccurrence in the future (CAPAs).
Ensure adequate installation of the solutions (CAPA-EV).
Implement process improvements by updating and improving Standard Operating Procedures.
Assist in training of staff on new or updated processes and procedures.
Analyse line performance data to define process improvements.
Required skills:
Bachelor degree (relevant education) in Automation Processes or Process Design (or the equivalent combination of education and experience).
Minimal 3 years' experience in an industrial environment.
Experience in a Good Manufacturing Practices (GMP) environment.
Experience investigating deviations to find root causes.
Have at least a basic understanding of what TMP is and what it stands for.
Analytical mind and curious to understand the details.
Quick to absorb new information.
Comfortable to reach out to other people within several departments and at different levels.
Technical writing skills.
Ability to meet deadlines and prioritize work.
Good communication skills (listening and discussing content) in English.
Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
