About The Role
A top pharmaceutical client is seeking a Senior Validation Engineer, to drive quality and compliance in a GMP manufacturing environment.
Key Responsibilities:
* Author, review, and execute validation/qualification documentation and change controls.
* Resolve technical issues during study execution.
* Collaborate with Production, Maintenance, and Quality teams on Cycle Development and Performance Qualification.
* Conduct root cause analysis for system failures and support continuous improvement via Lean Six Sigma.
* Represent validation in cross-functional projects and global forums.
* Ensure compliance with cGMP, global policies, and regulatory requirements through documentation, risk assessments, and audits.
* Support regulatory submissions and foster a compliant culture.
* Perform additional duties as assigned.
Required Skills & Experience:
* Expertise in cleaning validation (CIP/COP, TOC, ICP, swab methods, etc.).
* Proven experience in GMP manufacturing and technical project leadership.
* Knowledge of process monitoring, automation (e.g., DeltaV), and data systems (e.g., Pi System) is a plus.
* Familiarity with Irish, European, and international regulatory standards.
* Strong analytical, communication, and interpersonal skills.
* Proficiency in Microsoft Office and related applications.
* Experience with Sterile Fill-Finish, filter validation, CCI, or autoclave/SIP sterilization is advantageous.
Qualifications:
* Degree in Applied Pharmaceutical, Biological, Chemical Sciences, or Technical/Engineering.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
Please click ‘apply’ or contact Finlay Keyworth (Recruiter II) at Planet Pharma for more information:
E: fkeyworth@planet-pharma.co.uk
T: +44 20 3953 1451
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