Head Process Engineering & Validation – OM Pharma – Meyrin, GE

Head Process Engineering & Validation – Meyrin, GE – Indeed.ch

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To strengthen the growth of OM Pharma, we are currently looking for a Head Process Engineering & Validation for our manufacturing plant in Geneva. In this function, you report to the Head of Product and Industrial Development (P&ID). You will manage and share responsibilities with a team of two Validation Engineers. At this position, you will successfully establish and implement validation strategies as well as lead Process Engineering activities by ensuring compliance according to standards and international guidelines, assessing Validation gaps and delivering projects in due time. These activities will cover both Biotechnology and Pharmaceutical processes.

Your main missions are:

  • In the frame of Technical Projects, products LCM and compliance activities, ensure that all validation activities i.e. Manufacturing, Cleaning Processes & Transport Validation comply with GMP regulations in force

  • Establish and implement validation strategies, lead their execution in close collaboration with Manufacturing, QA, QC and P&ID teams: validations, continued process verification, periodic revalidations

  • Lead and bring new expertise for process engineering activities to improve process capability, quality and compliance: process mapping, identification of process improvement

  • Implement Continued Process Verification (CPV): monitoring and data analysis of process parameters by applying a statistical approach

  • Team management: supervise staff, develop the team & people, ensure reliability, meet deadlines, make decision in a timely manner, promote team cohesion and ownership, ensure operational effectiveness

  • Review and approve protocol and reports generated by the team, manage deviations, CAPA, change control, SOPs related to the activity

  • Act as Project Manager or Team Member for technical projects of the site: lead process engineering, validation for biotech & pharmaceutical manufacturing and cleaning processes

  • Contribute to prepare and review documents in support of CMC regulatory filings and addressing queries from HA’s related to validations

  • Act as a key interface with HA’s regarding validation topics (Q&A and inspections)

For this role, we are a looking for a strong technical and strategic leader, bringing the following profile:

  • PhD, Master, Engineer’s Degree in pharmaceutical sciences

  • 10 years experience in validation in biotech pharmaceutical industry in GMP environment

  • Extensive experience on Process engineering, Process Capability Management and Statistical analysis

  • Proven experience in Team Management

  • Cross functional skills (Manufacturing, QC, RA, QM)

  • Previous experience in Project Management

  • Fluent in French and English both in oral and written conversation.

To be successful in this new created role, we are looking for an experienced leader with capability to coach team members and flexibility to adapt to changes. You describe yourself as solution oriented, flexible and have an organized approach. Thanks to your communication skills, you easily develop new relationships and feel comfortable in a situation where you need to influence and convince others, internal and external stakeholders. Furthermore, your strategic thinking enable you to examine and understand issues from multiple points of view and your scientific analytical skills help you to identify challenges and hurdles.

The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Location: Switzerland – Meyrin/Geneva

Function: Technical Operations

Company: OM Pharma

Seniority Level: Manager

Talent Acquisition Consultant

+41 58 851 62 10

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