NB-Prospanica GSK - Validation Engineer
King of Prussia (Montgomery County) Design / Civil engineering / Industrial engineering
Job description
Details:
Why GSK? Because GSK's vision is to leverage its experience and technical capabilities to launch, supply, and manage products around the world. It will fulfill GSK's Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance – Being accountable for quality and safety.
The validation engineer will support the qualification of GxP systems across GMS manufacturing and laboratory areas and assure the validation program is compliant with global, site and industry practices.
Key responsibilities:
• You will support system (facility, process equipment, analytical instrument, cleaning process, computerized system) qualification/validation and projects by writing and executing validation protocols ensuring compliance with cGMPs.
• You will author final reports summarizing execution validation/qualification protocols and support documents (amendments, repeat test forms, addenda and deviations).
• You will interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
• You will assist in scheduling and coordination of validation activities with system owners and key stakeholders.
• You'll be responsible for periodic revalidation/requalification of major process equipment.
• You'll participate in change control reviews.
• You'll be responsible for continuous improvement of validation programs.
• You'll participate in site projects and initiatives as necessary.
• As necessary, you will be assigned to carry out laboratory based biopharmaceutical process development/investigational activities.
Contact information:
You may apply for this position online by selecting the Apply now button.
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jobDetails
Desired profile
Basic qualifications:
• BS/BA in a Scientific, Engineering or computer related discipline
• Industry- related experience (Validation, QA, QC, manufacturing).
Preferred qualifications:
• BS in Engineering
• Experience in validation or engineering in a pharmaceutical or FMCG manufacturing environment.