Validation Engineer (m/w/d)

☞ PQE Group

View: 142

Update day: 24-04-2024

Location: Solothurn Solothurn SO

Category: Pharmaceutical / Chemical / Biotech Part-time

Industry:

Job type: Temps plein, Temps partiel, Durée déterminée

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Job content

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors, with more than 900 employees and 26 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means joining a multicultural and challenging company in which you will be involved in international projects, working with colleagues from all over the world.

We are looking for a Technical Qualification Engineer to support our pharma project in Switzerland

Responsibilitiesinclude, but are not limited to, the following:

· Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports

· Development of installation, operational and performance qualification protocols for equipment and utilities(e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)

· Development of thermal validation study protocols

· Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested)

· Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)

· Development of risk-based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)

· Development of calibration and maintenance plans and related instructions

· Advanced knowledge of local GMPs

Requirements:

· Technical Degree(Engineering, Chemistry, Informatics, Physics, Mathematics)

· experience in the Pharmaceutical drug manufacturing area - Equipment and Utility validation

· Integrity, strong analytical skills and attention to details

Location:

Solothurn (Switzerland)

Languages:

Fluent German (at least B2/C1 Level)

Fluent English (at least B2/C1 Level)

Why PQE:

PQE Group is a leading quality solution provider for the Life Science industry, in both high level and hands on consulting services around the world. With 26 offices and a global presence, the PQE Group supports small, medium and large sized organizations in their development and compliance related challenges with specific capabilities in: Data Integrity Assurance, Digital Governance, Qualification & Engineering, Laboratory Exellence, Quality Compliance, Regualtory Affaris and Audits.

Vertragsdauer: 12 Monate

Voraussichtliches Einstiegsdatum: 17.1.2022

Art der Stelle: Vollzeit, Teilzeit, Temporär/Befristet, Freie Mitarbeit

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Deadline: 08-06-2024

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