Process Validation Engineer

SKAN AG; Allschwil; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Open corporate culture

Freedom for ideas

Short decision paths

Job-oriented training

Open communication policy

5 weeks holidays

Zusammenfassung

SKAN AG in Allschwil, Switzerland seeks a Process Validation Engineer (PVE) for the PVM department. The role involves developing and validating decontamination processes (H2O2 and E-Beam) for pharmaceutical isolators and requires up to 50% international travel to customers.

You work in a diverse team, creating test protocols, reports and training customers. Travel across borders is expected and the position offers a competitive benefits package.

Qualifikationen

• University degree in life sciences, engineering, or technology.
• Experience with sterilisation technologies and/or isolator decontamination (H2O2 and/or e-beam) is welcome.
• Experience in cleanroom qualification in medical device/pharma.
• Experience in process validation (IQ/OQ/PQ) is an advantage.
• Very good knowledge of English; other languages a plus.

Aufgaben

• Develop, validate and implement decontamination processes.
• Create test protocols and test reports.
• Enable customer-oriented decontamination processes with maximum safety and efficiency.
• Process optimisation and requalification; customer-oriented troubleshooting and consulting.
• Carry out internal and external training for customers.
• Support cross-functional improvements and updates to SOPs and workflows.

Kenntnisse

English proficiency

Sterilisation technologies

Isolator decontamination

Process validation (IQ/OQ/PQ)

Ausbildung

Bachelor’s or Master’s degree (life sciences / engineering / technology)

Jobbeschreibung

Process Validation Engineer

Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor‑made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories.

At SKAN, healthy growth is important to us. We are always looking for talented individuals to fill a wide range of roles.

Overview

We are looking for a motivated Process Validation Engineer (PVE) for the Process Validation Microbiology (PVM) department. The PVM team consists of professionals with a wide range of cultural, academic and professional backgrounds. Our team specialises in the development and validation of decontamination processes (H2O2 and E-Beam) for pharmaceutical isolators, which are a key element in the aseptic manufacturing of sterile drugs. As a member of this team, you will have the opportunity to travel worldwide to support our pharmaceutical customers in their life‑saving projects. This role therefore involves up to 50% international travel to our customers.

Responsibilities

• Development, validation and implementation of decontamination processes
• Creation of test protocols and test reports
• Enabling customer‑orientated decontamination processes with maximum safety and efficiency
• Process optimisation and requalification of existing processes as well as customer‑oriented troubleshooting and consulting
• Carrying out internal and external training for customers
• Supporting cross-functional technological improvements and innovations
• Assisting with the maintenance, updating and improvement of internal SOPs, documentation and workflows

Hardskills

• A university degree (Bachelor's or Master's) in life sciences, engineering or technology is required
• Experience in one of the sterilisation technologies (steam, irradiation or ETO) and/or isolator decontamination (H2O2 and/or e-beam) is very welcome
• Experience in cleanroom qualification in the medical device and/or pharmaceutical industry is also appreciated
• Experience in process validation (IQ/OQ/PQ) is an advantage
• Very good knowledge of English is required, any other foreign language is a plus

Softskills

• You have a professional, reliable way of working, especially for customer contact (internal and external) and can take on personal responsibility
• Furthermore you are a motivated person who likes to work carefully and in compliance with GMP
• You are comfortable dealing with different cultures and enjoy working with others in a collegial and team‑oriented manner
• You are flexible, especially beacause of the fact that assignments cannot always be planned far in advance

We offer you

• An open and collegial corporate culture
• Freedom for ideas
• Short decision‑making paths and flat hierarchies
• Job‑oriented introduction and training
• Open communication policy
• Participation in sports and leisure activities
• 5 weeks holidays and the possibility of further holidays

Job details

• Work location 4123 Allschwil (BL)
• Workload 100%
• Employment start By agreement
• Employment duration Permanent
• By online Online form