Operations Start-up Lead till läkemedelsbolag (2184)

VI OFFERERAR LÖPANDE, DET KAN INNEBÄRA ATT UPPDRAGET STÄNGS I FÖRTID

SVAR SNARAST, SENAST 5/1

• Start: januari
• Slut: 4-6 månader
• Omfattning: 100 %
• Antal: 1 st
• Plats: Uppsala
• Möjlighet till distans: Generellt sker arbete på plats. Viss tid på distans ok, enligt ök
• Krav på svenska: Nej, men ett plus
• Krav på engelska: Ja
• Säkerhetsklassat uppdrag: Nej
• Takpris: Förhandlingsbart

För kundsräkning söker vi nu en erfaren Operations Start-up Lead

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.

– Bachelor’s or master’s 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

Handlingar som skall ingå vid svar av förfrågan

• engelska

• Svar på SKA- och BÖR-krav (använd denna) ****

• Ange konsultens tillgänglighet samt önskat arvode.

• Referensuppdrag (om vi går vidare med din konsult / dig kommer vi att be om referenser)

För frågor om uppdraget:

Johan Antonsson, /

Sök uppdraget genom att fylla i och skicka in formuläret nedan.

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