Validation Engineer
GSK is currently looking for a Validation Engineer to join our team in Rockville, MD.
The primary responsibility is to support the qualification of GxP analytical instruments, computerized systems as well as facility/utilities/process equipment across GMS Rockville for various capital projects.
Assure that the validation program is compliant with global, site and industry practices.
KEY
Responsibilities:
Support facility/utilities/process equipment, analytical instrument, computerized system validation activities for various capital projects by writing and executing validation protocols.
Author all required validation lifecycle documents ensuring compliance with cGMPs as well as above site policies and procedures.
Author final reports summarizing execution of validation protocols and support documents (amendments, repeat test forms, addenda and deviations).
Responsible for continuous improvement of validation program and assuring compliance with GSK policies and procedures.
Interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
Interface with regulatory authorities and partners as the SME for the validation program.
Provide leadership and technical decision-making regarding cGMP compliance, validation strategy, and quality systems.
Schedule and coordinate validation activities with vendors, system owners, engineering and key stakeholders.
Ensure timely CAPA and change control execution and closure.
Participate in site projects and initiatives as necessary.
Trained in self inspections and participate in >25% of department's self inspections.
Why you?Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS/BA in a Scientific, Engineering, Computer Science or equivalent related disciplinePreferred
Qualifications:
If you have the following characteristics, it would be a plus:
Minimum of 1 years of industry-related experience (Validation, QA, QC, manufacturing) and minimum of 1 year of hands-on validation experience.
Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
Experience with SAP and Veeva is preferred.
Familiar with the operation and qualification of utilities, process equipment, computerized systems and analytical instruments used within biopharmaceutical manufacturing and QC labs High level of IT literacy and experience with IT applications is preferred (SAP, Veeva, DeltaV, PLCs, Unicorn, Siemens Building Automation System, etc.
).
Understanding of the requirements of a Biopharma/regulated environment.
Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.
Extensive knowledge of 21 CFR 11 requirements.
Strong planning and program management skills.
Effective organization, communication, presentation and influencing skills.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
The primary responsibility is to support the qualification of GxP analytical instruments, computerized systems as well as facility/utilities/process equipment across GMS Rockville for various capital projects.
Assure that the validation program is compliant with global, site and industry practices.
KEY
Responsibilities:
Support facility/utilities/process equipment, analytical instrument, computerized system validation activities for various capital projects by writing and executing validation protocols.
Author all required validation lifecycle documents ensuring compliance with cGMPs as well as above site policies and procedures.
Author final reports summarizing execution of validation protocols and support documents (amendments, repeat test forms, addenda and deviations).
Responsible for continuous improvement of validation program and assuring compliance with GSK policies and procedures.
Interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
Interface with regulatory authorities and partners as the SME for the validation program.
Provide leadership and technical decision-making regarding cGMP compliance, validation strategy, and quality systems.
Schedule and coordinate validation activities with vendors, system owners, engineering and key stakeholders.
Ensure timely CAPA and change control execution and closure.
Participate in site projects and initiatives as necessary.
Trained in self inspections and participate in >25% of department's self inspections.
Why you?Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS/BA in a Scientific, Engineering, Computer Science or equivalent related disciplinePreferred
Qualifications:
If you have the following characteristics, it would be a plus:
Minimum of 1 years of industry-related experience (Validation, QA, QC, manufacturing) and minimum of 1 year of hands-on validation experience.
Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
Experience with SAP and Veeva is preferred.
Familiar with the operation and qualification of utilities, process equipment, computerized systems and analytical instruments used within biopharmaceutical manufacturing and QC labs High level of IT literacy and experience with IT applications is preferred (SAP, Veeva, DeltaV, PLCs, Unicorn, Siemens Building Automation System, etc.
).
Understanding of the requirements of a Biopharma/regulated environment.
Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.
Extensive knowledge of 21 CFR 11 requirements.
Strong planning and program management skills.
Effective organization, communication, presentation and influencing skills.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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