Senior Associate Manufacturing (33320)

Orion Group Life Sciences are looking for 2 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

Support the primary production process in process (SOP's, deviations, CAPA's) and system (MES).

Drive continuous improvement of the primary production process by means of electronic Batch Record (MES) improvements.

Main Responsibilities of the role

• Support primary production process through MES.
• Work within full GMP compliance.
• Design and improve electronic batch records (GMBR's) to support the production process.
• Drive lifecycle management for MES, GMBR's, PVL's and PMBR's.
• Provide on-call MES support to primary production process.
• Set up and maintain MES related (GMP) training material.
• Train Production staff on new or revised processes.
• Improve MES quality and performance.
• Actively participate in continuous improvement initiatives (e.g., Kaizen/Agility).
• Create proposals and implement initiatives to:
  • Further develop and train PRD staff on MES.
  • Develop and improve eBR process.
  • Optimize MES system capabilities for ABR.
• Support Operation Improvement Team (OIT).
• Own NC's, CAPA's, CAPA-EV's and Change Records.
• Perform change assessments for production area.
• For MES, assist in (internal) audits/inspections.
• Develop, revise, and maintain production related (GMP) documentation (SOP's and FORM's).
• Acts as Advise Giver for PAS|X system and process design principles/improvement initiatives on site level.
• Acts as Advise Giver for peers, Global MES network, PRD Mgmt and site Mgmt for PAS|X related issues/solutions.
• Stable Process Performance through GMBR, PVL and PMBR lifecycle management.
• Improved Processes by identifying and implementing (continuous) improvement initiatives for the primary production process.
• Problem Solving by shop floor 1st line trouble shooting and on-call support.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orioneng.com or contact Tim on 0044 7593448607

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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.