Validation Engineer
Job Details:
Industry:
Biopharmaceutical Work Location:
Gaithersburg, MD Job Title:
Validation Engineer Duration:
12 Months (Temporary/Contract)
Job Description:
The Validation Engineer will be responsible for developing and implementing equipment (facilities, formulation/fill, packaging, and Quality Control), cleaning, sterilization, computer/automation, shipping, and method validation strategies by incorporating good engineering practices, risk-based validation principles and the regulatory requirements.
The Validation Engineer will collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle.
The Validation Engineer will continually ensure systems and facilities comply with regulatory and Quality process requirements.
Major Responsibilities Participates in system design and commissioning project phases.
Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification.
Generates Validation Project Plan for complex projects and systems Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments and Automation Risk Assessments Authors Validation Protocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes.
Authors Validation Protocols and Reports for Controlled Temperature Units.
Supports Periodic Assessments on required frequency intervals Performs Revalidations on required frequency interval Resolves technical issues encountered during study execution Schedules resources to approve and execute validation documents Participating in SOP development as needed Supports equipment start-up, shakedown, and cycle development Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle Implements/maintains governing cGMP procedures Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures Author and review change control documents Why Kelly? As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire Apply Today! Why Kelly (R) Engineering? Your engineering skills are in demand, but how do you find the right fit? Easy.
At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges.
We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth.
Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly (R) At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential.
In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?).
Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.
At Kelly, we believe that the more inclusive we are, the better services we can provide.
Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws.
A conviction does not automatically bar individuals from employment.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Industry:
Biopharmaceutical Work Location:
Gaithersburg, MD Job Title:
Validation Engineer Duration:
12 Months (Temporary/Contract)
Job Description:
The Validation Engineer will be responsible for developing and implementing equipment (facilities, formulation/fill, packaging, and Quality Control), cleaning, sterilization, computer/automation, shipping, and method validation strategies by incorporating good engineering practices, risk-based validation principles and the regulatory requirements.
The Validation Engineer will collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle.
The Validation Engineer will continually ensure systems and facilities comply with regulatory and Quality process requirements.
Major Responsibilities Participates in system design and commissioning project phases.
Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification.
Generates Validation Project Plan for complex projects and systems Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments and Automation Risk Assessments Authors Validation Protocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes.
Authors Validation Protocols and Reports for Controlled Temperature Units.
Supports Periodic Assessments on required frequency intervals Performs Revalidations on required frequency interval Resolves technical issues encountered during study execution Schedules resources to approve and execute validation documents Participating in SOP development as needed Supports equipment start-up, shakedown, and cycle development Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle Implements/maintains governing cGMP procedures Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures Author and review change control documents Why Kelly? As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire Apply Today! Why Kelly (R) Engineering? Your engineering skills are in demand, but how do you find the right fit? Easy.
At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges.
We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth.
Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly (R) At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential.
In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?).
Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.
At Kelly, we believe that the more inclusive we are, the better services we can provide.
Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws.
A conviction does not automatically bar individuals from employment.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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