Joulé
Job Title:
Commissioning/Qualification Specialist/ValidationLocation:
Warren, NJHours/Schedule:
Mon - Fri, Business HoursType:
Contract OverviewLeading Biopharmaceutical company looking for experienced Engineer.
Ideal candidates should have 3-5 years of experience with airflow visualization, calibration management, cell therapy manufacturing equipment, commissioning and qualification of common utilities, and regulatory operations ResponsibilitiesCommissioning and Qualification:
Administer change control activities and corrective and preventive actions.
Review, approve, and execute test protocols, validation deliverables, and plans as needed.
Author, review, and approve SOPs, work practices, and other procedural documents.
Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.
Promotes and provides excellent customer service and support:
Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on equipment commissioning and qualification.
Interfaces with customers to ensure all expectations are met.
Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Communication and Management of Timelines:
Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel.
Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders.
Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
Regulatory
Responsibilities:
Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other BMS standards and regulations.
Acts as equipment commissioning and qualification SME in internal and regulatory audits.
RequirementsBS in Engineering required.
Must be able to read and understand construction and mechanical drawings and P&IDs.
Minimum of 7 years of experience in FDA-regulated industry.
Minimum of 3 years of experience executing projects of low to medium complexity.
Strong background and experience in laboratory and manufacturing operations.
Knowledge of cGMP in the pharmaceutical industry.
Thorough knowledge and hands-on experience in commissioning and qualification of common utilities, such as DI water, compressed gases, process air, liquid nitrogen supply systems, AHUs, and autoclaves.
Thorough knowledge of and hands-on experience with operation and qualification of cell therapy manufacturing equipment, including isolators, vial fillers, and vial cappers.
Knowledge and hands-on experience with airflow visualization (smoke studies).
Advanced knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment.
Advanced knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.
Advanced knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed gas systems, liquid nitrogen supply systems, autoclaves, isolators, filling and capping equipment, and airflow visualization studies.
High proficiency in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook.
BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3About the Company:
Joul Our StoryImpacting lives.
It's in our DNA.
At Joul , we believe our world is filled with possibilities - where character, integrity and commitment drive our purpose.
For over 30 years, Joul has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent.
Operating at the forefront of the life sciences arena, Joul 's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects.
Joul is a System One division.
Joul consists of multiple business lines working together for client success:
scientific, clinical, and healthcare recruiting plus equipment services.
Since our existence, we've excelled in these specialized markets, and in recent years we have further narrowed the Joul brand to exclusively represent these arenas.
Joul 's services are backed by the considerable reach and resources of our parent company, System One.
The Business of ScienceWay back before STEM was a trend, Joul established its roots in scientific and technical disciplines.
We began life as an engineering services firm, but our business has evolved considerably to where it stands today:
A leader in specialized workforce solutions and integrated servicesOne of the top ten largest clinical and scientific staffing firms in the U.
S.
An ISO-certified provider of laboratory and facility supportAn advocate for scientific, clinical, and healthcare clients and candidates alikeNational Reach with Local ExpertiseWorking at the intersection of business and science, we make it easier to recruit and deploy talent for ongoing work and on-demand projects in a host of disciplines.
We're still writing our story, but our future is built on a foundation of quality delivery and personalized service.
Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
0Website:
https:
//www.
jouleinc.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
Commissioning/Qualification Specialist/ValidationLocation:
Warren, NJHours/Schedule:
Mon - Fri, Business HoursType:
Contract OverviewLeading Biopharmaceutical company looking for experienced Engineer.
Ideal candidates should have 3-5 years of experience with airflow visualization, calibration management, cell therapy manufacturing equipment, commissioning and qualification of common utilities, and regulatory operations ResponsibilitiesCommissioning and Qualification:
Administer change control activities and corrective and preventive actions.
Review, approve, and execute test protocols, validation deliverables, and plans as needed.
Author, review, and approve SOPs, work practices, and other procedural documents.
Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.
Promotes and provides excellent customer service and support:
Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on equipment commissioning and qualification.
Interfaces with customers to ensure all expectations are met.
Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Communication and Management of Timelines:
Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel.
Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders.
Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
Regulatory
Responsibilities:
Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other BMS standards and regulations.
Acts as equipment commissioning and qualification SME in internal and regulatory audits.
RequirementsBS in Engineering required.
Must be able to read and understand construction and mechanical drawings and P&IDs.
Minimum of 7 years of experience in FDA-regulated industry.
Minimum of 3 years of experience executing projects of low to medium complexity.
Strong background and experience in laboratory and manufacturing operations.
Knowledge of cGMP in the pharmaceutical industry.
Thorough knowledge and hands-on experience in commissioning and qualification of common utilities, such as DI water, compressed gases, process air, liquid nitrogen supply systems, AHUs, and autoclaves.
Thorough knowledge of and hands-on experience with operation and qualification of cell therapy manufacturing equipment, including isolators, vial fillers, and vial cappers.
Knowledge and hands-on experience with airflow visualization (smoke studies).
Advanced knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment.
Advanced knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.
Advanced knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed gas systems, liquid nitrogen supply systems, autoclaves, isolators, filling and capping equipment, and airflow visualization studies.
High proficiency in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook.
BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3About the Company:
Joul Our StoryImpacting lives.
It's in our DNA.
At Joul , we believe our world is filled with possibilities - where character, integrity and commitment drive our purpose.
For over 30 years, Joul has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent.
Operating at the forefront of the life sciences arena, Joul 's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects.
Joul is a System One division.
Joul consists of multiple business lines working together for client success:
scientific, clinical, and healthcare recruiting plus equipment services.
Since our existence, we've excelled in these specialized markets, and in recent years we have further narrowed the Joul brand to exclusively represent these arenas.
Joul 's services are backed by the considerable reach and resources of our parent company, System One.
The Business of ScienceWay back before STEM was a trend, Joul established its roots in scientific and technical disciplines.
We began life as an engineering services firm, but our business has evolved considerably to where it stands today:
A leader in specialized workforce solutions and integrated servicesOne of the top ten largest clinical and scientific staffing firms in the U.
S.
An ISO-certified provider of laboratory and facility supportAn advocate for scientific, clinical, and healthcare clients and candidates alikeNational Reach with Local ExpertiseWorking at the intersection of business and science, we make it easier to recruit and deploy talent for ongoing work and on-demand projects in a host of disciplines.
We're still writing our story, but our future is built on a foundation of quality delivery and personalized service.
Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
0Website:
https:
//www.
jouleinc.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
