Cleaning Validation Engineer
AI Summary
Responsible for cleaning validation and re-validation of process and packaging equipment at a pharmaceutical manufacturing site, including protocols, sampling, cleaning limits and acceptance criteria under GMP. Works closely with production and other departments to keep cleaning processes validated.
About this role
Cleaning Validation Engineer – Helsingborg
At WeQuel, we connect skilled specialists with exciting assignments across Life Science and industry. We are now looking for an energetic Cleaning Validation Engineer for an assignment with a global consumer healthcare company at its manufacturing site in Helsingborg. The site produces over-the-counter medicines for the global market. You will join the Technical Operations team.
The assignment
You will be responsible for cleaning validation and re-validation of the process and packaging equipment used for the site’s marketed products. You will assess and set acceptance criteria for cleaning validation. You will also help improve cleaning validation processes and systems so the cleaning processes stay in a validated state.
Your responsibilities
Prepare cleaning validation protocols and reports on time, in line with the Validation Master Plan (VMP) and project timelines.
Execute cleaning validation, including:
preparing the documentation needed for the validation runs
training and coordinating the production staff involved
performing sampling and analysis of samples.
Calculate cleaning limits and set acceptance criteria.
Collaborate with all departments to make validation and re-validation successful.
Update and improve cleaning instructions and validation processes as needed.
Follow the relevant SOPs and complete the training required for the role.
Requirements
Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutics or equivalent.
Proven hands-on experience of cleaning validation, including sampling techniques.
Fluent Swedish and English, spoken and written.
Meriting
Experience of calculating cleaning limits.
Experience of analytical methods.
Experience of leading a project team towards a defined goal.
Strong technical writing and documentation skills to GMP standards.
Excellent knowledge of GMP requirements.
Who you are
You are energetic, driven and have a strong work ethic. You know cleaning validation thoroughly and enjoy working close to production. You thrive in a Technical Operations team, collaborate easily with colleagues across functions, and can plan and drive activities on your own.
Assignment details
Location: Helsingborg
Scope: full time (100%)
Remote: on site (0% remote)
Start: 1/12-26
Apply
Send your application today. We review applications continuously and the position may be filled before the application deadline.
Det här har jag medvetet utelämnat ur annonsen: kundens namn, produkt- och varumärkesnamn samt pris. Startdatum, slutdatum och omfattning fanns inte i underlaget. Jag har därför skrivit “as agreed”, 100 % och onsite som standardvärden. Justera dem om kunden har angett något annat.
Vill du att jag skapar uppdraget i Cinode (Sales Pipeline, inkorg) med den här annonsen som rollbeskrivning?
Skills
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