Jubilant HollisterStier CMO
Validation Supervisor
Jubilant HollisterStier CMO, Spokane, Washington, United States, 99201
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.
Our Promise:Caring, Sharing, Growing
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.
Job Description:
The Validation Supervisor supervises Validation Associates. The Validation Supervisor coordinates and schedules validation activities both within the Validation team and with internal stakeholders. The Validation Supervisor also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards.
Responsibilities:Supervises validation associates.Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors and approves equipment requalification reports to provide documented evidence of equipment requalifications.Revises and approves validation SOPs to ensure correct and up to date information and processes are followed.Demonstrates a working knowledge of the operation of various equipment and systems such as lyophilizers, terminal sterilizers, tanks, autoclaves, dry heat ovens, rinsers, CIP and SIP systems, HVAC, aseptic processing areas, etc.Coordinates and schedules equipment requalifications to ensure on time execution. Coordinates with validation, manufacturing, and engineering (as needed) to ensure alignment with proposed validation work schedules and appropriate resource needs are agreed upon.Initiates deviations within the EQMS system. Assist with RCA and authors impact assessments. Completes minor deviations. Authors and approves change controls and CAPAs. Approves deviations as a department approver.
Qualifications:HS Diploma or equivalent5 years validation experience (3 years with an AS, 1 year with a BS)Supervisor, pharmaceutical, and FDA regulated industryProficiency in standard business computer applications (i.e. Microsoft Outlook, Word, Excel, PowerPoint, etc.).Proficiency with EQMS, LMS, and EDMS.Technical writingMechanical aptitude
Shift:
Day
Compensation:The salary range for this position is $76,000 – 142,800 depending on experience.
Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibits outstanding performance over a period of time in the role
Benefits:Medical, Dental, Vision, Flexible Spending and Health Savings AccountsLife, AD&D, Short and Long Term Disability401(k) with company matchGenerous paid time off planEmployee Assistance Program
Optional Benefits:Voluntary Life and AD&D for employee & familySupplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)Pet InsuranceID Theft ProtectionPerk Spot Discount Program
Jubilant HollisterStier is a great place to grow!If you’re up for a rewarding challenge, we invite you to take the first step and apply today!
https://www.jublhs.com/careers/career-opportunitiesPlease click on the Spokane, WA link
Jubilant HollisterStier is an EEO/AA Employer.All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability.
If you require assistance applying for a position, please contact our HR Department at:HResources@jhs.jubl.com
Our Promise:Caring, Sharing, Growing
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.
Job Description:
The Validation Supervisor supervises Validation Associates. The Validation Supervisor coordinates and schedules validation activities both within the Validation team and with internal stakeholders. The Validation Supervisor also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards.
Responsibilities:Supervises validation associates.Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors and approves equipment requalification reports to provide documented evidence of equipment requalifications.Revises and approves validation SOPs to ensure correct and up to date information and processes are followed.Demonstrates a working knowledge of the operation of various equipment and systems such as lyophilizers, terminal sterilizers, tanks, autoclaves, dry heat ovens, rinsers, CIP and SIP systems, HVAC, aseptic processing areas, etc.Coordinates and schedules equipment requalifications to ensure on time execution. Coordinates with validation, manufacturing, and engineering (as needed) to ensure alignment with proposed validation work schedules and appropriate resource needs are agreed upon.Initiates deviations within the EQMS system. Assist with RCA and authors impact assessments. Completes minor deviations. Authors and approves change controls and CAPAs. Approves deviations as a department approver.
Qualifications:HS Diploma or equivalent5 years validation experience (3 years with an AS, 1 year with a BS)Supervisor, pharmaceutical, and FDA regulated industryProficiency in standard business computer applications (i.e. Microsoft Outlook, Word, Excel, PowerPoint, etc.).Proficiency with EQMS, LMS, and EDMS.Technical writingMechanical aptitude
Shift:
Day
Compensation:The salary range for this position is $76,000 – 142,800 depending on experience.
Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibits outstanding performance over a period of time in the role
Benefits:Medical, Dental, Vision, Flexible Spending and Health Savings AccountsLife, AD&D, Short and Long Term Disability401(k) with company matchGenerous paid time off planEmployee Assistance Program
Optional Benefits:Voluntary Life and AD&D for employee & familySupplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)Pet InsuranceID Theft ProtectionPerk Spot Discount Program
Jubilant HollisterStier is a great place to grow!If you’re up for a rewarding challenge, we invite you to take the first step and apply today!
https://www.jublhs.com/careers/career-opportunitiesPlease click on the Spokane, WA link
Jubilant HollisterStier is an EEO/AA Employer.All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability.
If you require assistance applying for a position, please contact our HR Department at:HResources@jhs.jubl.com