Validation Engineer
Job Details:
Industry:
Biopharmaceutical Work Location:
West Chester, OH Job Title:
Validation Engineer Duration:
6 Months (Temporary/Contract)
Job Description:
Seeking strong contract validation professionals to lead and develop validation protocols, coordinate the execution of protocols, lead team to discrepancy resolution and trace requirements to qualification documentation for a new Vaccine Formulation and Filling line.
These roles will work closely with the project CQV Lead and other project personnel to achieve these deliverables specific to the new line.
The project consists of the following work streams, and each Contract Senior Validation Engineer will be primarily dedicated to a specific work stream:
o Component Preparation and Processing, consisting primarily of:
o ATEC Component Prep and Processing Equipment o Sterilizing Autoclave o Parts Washer o CIP/SIP o Filling, consisting primarily of the following:
o Vial Washer o Depyrogenation Tunnel o Vial Liquid Filler and Stoppering o Vial Capper o Open Active RABS o Swing Conveyor and Wall Transfer Mousehole o SCADA and Batch Management o Particle Counters Duties:
Working closely with the project CQV Lead, Equipment Vendors, PET Facilitators, Operation personnel, and project leads, to execute the project Validation related to Component Preparation and Processing and Vial Filling.
The major duties included in this role are as follows.
o Coordinate with equipment vendors to develop installation and operation qualification documents.
Vendor is expected to bring 80% of the details required to the protocol and the lead is to take the document the remaining 20%.
o Lead the development of gap qualification protocols.
These are the qualification requirements that are not include in the vendor issues protocols (i.
e.
calibration verification, maintenance plans, SOPs drafted, missing functionality, etc.
).
o Planning and guiding the work of Junior Validation Engineers.
o Lead the execution of IQ/OQ protocols.
Own the discrepancy generation, coordination and closure.
Report generation and closure.
o Assist with the generation and process qualification protocols and the execution, discrepancy resolution and closure and report writing as it relates to the Filler and Isolator.
o Assist with system assessments.
o Reporting progress on the activities listed above to the project CQV Lead.
Qualifications:
Education:
Engineering or technical degree preferred
Experience:
oMinimum 5-7 years GxP experience in respective work stream area (Component Prep/Processing/Filling oMultiple project experience leading a validation team.
oFilling Work Steam Lead:
Experience with RABS These additional experiences are a plus:
o COVID/Vaccine project experience 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 ? Your engineering skills are in demand, but how do you find the right fit? Easy.
With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology.
Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
About Kelly 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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy.
Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Industry:
Biopharmaceutical Work Location:
West Chester, OH Job Title:
Validation Engineer Duration:
6 Months (Temporary/Contract)
Job Description:
Seeking strong contract validation professionals to lead and develop validation protocols, coordinate the execution of protocols, lead team to discrepancy resolution and trace requirements to qualification documentation for a new Vaccine Formulation and Filling line.
These roles will work closely with the project CQV Lead and other project personnel to achieve these deliverables specific to the new line.
The project consists of the following work streams, and each Contract Senior Validation Engineer will be primarily dedicated to a specific work stream:
o Component Preparation and Processing, consisting primarily of:
o ATEC Component Prep and Processing Equipment o Sterilizing Autoclave o Parts Washer o CIP/SIP o Filling, consisting primarily of the following:
o Vial Washer o Depyrogenation Tunnel o Vial Liquid Filler and Stoppering o Vial Capper o Open Active RABS o Swing Conveyor and Wall Transfer Mousehole o SCADA and Batch Management o Particle Counters Duties:
Working closely with the project CQV Lead, Equipment Vendors, PET Facilitators, Operation personnel, and project leads, to execute the project Validation related to Component Preparation and Processing and Vial Filling.
The major duties included in this role are as follows.
o Coordinate with equipment vendors to develop installation and operation qualification documents.
Vendor is expected to bring 80% of the details required to the protocol and the lead is to take the document the remaining 20%.
o Lead the development of gap qualification protocols.
These are the qualification requirements that are not include in the vendor issues protocols (i.
e.
calibration verification, maintenance plans, SOPs drafted, missing functionality, etc.
).
o Planning and guiding the work of Junior Validation Engineers.
o Lead the execution of IQ/OQ protocols.
Own the discrepancy generation, coordination and closure.
Report generation and closure.
o Assist with the generation and process qualification protocols and the execution, discrepancy resolution and closure and report writing as it relates to the Filler and Isolator.
o Assist with system assessments.
o Reporting progress on the activities listed above to the project CQV Lead.
Qualifications:
Education:
Engineering or technical degree preferred
Experience:
oMinimum 5-7 years GxP experience in respective work stream area (Component Prep/Processing/Filling oMultiple project experience leading a validation team.
oFilling Work Steam Lead:
Experience with RABS These additional experiences are a plus:
o COVID/Vaccine project experience 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 ? Your engineering skills are in demand, but how do you find the right fit? Easy.
With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology.
Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
About Kelly 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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy.
Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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