Operations Start-up Lead till läkemedelsbolag

Professional Galaxy is an IT and technology consulting company that provides highly specialized expertise within IT software development SAP purchasing electronics and mechanical design. We collaborate with experienced senior experts and deliver strategic value-creating expertise to some of Swedens most complex and analytically demanding projects. Our focus is always on high quality professionalism and clear measurable results.

Are you the right person for the assignment or do you want to recommend a strong candidate Do not hesitate to contact us.

Apply today selection and interviews are ongoing.

We are now looking for an Operations Start-up Lead till läkemedelsbolag for one of our clients.

Assignment Description

The Operations Start-up Lead is responsible for establishing and leading the operational readiness activities required to support full-scale manufacturing operations. This includes developing the staffing plan implementing training programs configuring digital systems such as LIMS/ERP setting up production and material planning processes defining the operating system and ensuring validation activities such as Performance Qualification (PQ) are successfully executed. The role will work cross-functionally with Operations Quality Supply Chain IT and Engineering to ensure a robust compliant and efficient start-up of manufacturing activities.

Profile:
Bachelors or masters degree in engineering Life Sciences or related field.
- 10-12 years work experience in a pharmaceutical or medical devices industry.
- Experience with manufacturing start-up tech transfer or operational readiness projects.
- Strong understanding of GMP digital systems (LIMS/ERP/MES) and validation principles.
- Excellent cross-functional leadership communication and project management skills.
- A working knowledge of relevant GMP and ISO 13485 standards and regulations.

Overall:

A program to prepare a manufacturing site for operation by establishing people training systems planning operating practices and validation activities to ensure compliant efficient ramp-up and steady-state production.

Create a staffing strategy across manufacturing quality logistics and support.

Define role profiles competencies and resource levels by phase; partner with HR for hiring/onboarding; monitor and adjust against demand forecasts.

Build a structured training program with SOP-based curricula and qualification assessments.

Ensure compliance with regulatory/GMP requirements and track training completion/readiness.

Configure and deploy LIMS and ERP to support manufacturing QC inventory and documentation.

Capture user requirements workflows and master data; coordinate testing validation training and system integrations.

Implement end-to-end production scheduling and material planning (MRP) inventory and replenishment strategies.

Define the site operating system: standard work tiered meetings KPIs and performance routines.

Document procedures and work instructions apply lean methods and drive continuous improvement.

Plan and execute PQ per the validation master plan testing equipment/systems/processes under real conditions.

Work closely with Quality to ensure regulatory-compliant documentation and readiness for final approval.

Tracks trends develops and implements equipment and/or process enhancements that will improve efficiency product yield and equipment reliability.

Ensures that process and material quality objectives are met during project and are congruent with requirements.

Establishes process and material quality targets Measures performance against targets and provides remedial actions as necessary.

Responsible for financial forecasting and spend performance.

Start date:

Duration: 4-6 månader

Location: Uppsala

Application Deadline:

Please apply directly through our system with:

- Your updated CV

- Availability to start the assignment

In the motivation describe why you are suitable for this assignment - refer to previous consulting assignments employment education and personal qualities.

Please note: We do not accept any applications through mail. All applications have to be sent through the portal to be valid.

Offer continuously: Please note that for this role we offer continuously. That means that we sometimes remove the assignments before the deadline. If you are interested we recommend that you apply immediately.