Jubilant HollisterStier CMO
Validation Specialist
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:
Validation Specialist IThe primary function of the Validation Specialist is to participate on project teams that are responsible for the installation and upgrade of critical systems and equipment used in the manufacturing of pharmaceutical products.
Validation Specialist IIThe Validation Specialist II serves on project teams in support of capital, compliance, and contract projects while demonstrating technical validation expertise. The Validation Specialist II also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards. The Validation Specialist II also mentors less experienced Validation Associates and Specialists.
Sr. Validation SpecialistThe Sr. Validation Specialist serves on project teams in support of complex capital, compliance, and contract projects while demonstrating expert technical validation expertise. The Sr. Validation Specialist also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards. The Sr. Validation Specialist also mentors less experienced Validation Associates and Specialists.
Responsibilities, Validation Specialist I:Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors equipment requalification reports to provide documented evidence of equipment requalifications.Under the guidance of experienced validation personnel, authors SOPs for requalification of new equipment. Revises validation SOPs to ensure correct and up to date information and processes are followed.Developing a working and theoretical 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.Initiates deviations within the EQMS system. Assist with RCA and impact assessments. Completes minor deviations. Under the guidance of experienced validation personnel, authors change controls and CAPAs.Under the guidance of experienced validation personnel, authors validation protocols and reports in support of validation projects.Developing a working knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach.
Responsibilities, Validation Specialist II:Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors equipment requalification reports to provide documented evidence of equipment requalifications.Authors SOPs for requalification of new equipment. Revises validation SOPs to ensure correct and up to date information and processes are followed.Demonstrates a working and theoretical 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.Initiates deviations within the EQMS system. Assist with RCA and impact assessments. Completes minor deviations. Authors change controls and CAPAs.Authors validation protocols and reports in support of validation projects.Demonstrates a working knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach.
Responsibilities, Sr. Validation Specialist:Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors equipment requalification reports to provide documented evidence of equipment requalifications.Authors SOPs for requalification of new equipment. Revises validation SOPs to ensure correct and up to date information and processes are followed. Approves SOPs as a department approver.Demonstrates an expert working and theoretical 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.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.Authors validation protocols and reports, developing validation strategies for complex validation projects.Demonstrates an expert knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach.
Qualifications:Proficiency in standard business computer applications (i.e. Microsoft Outlook, Word, Excel, PowerPoint, etc.).Proficiency with EQMS, LMS, and EDMS.Technical writingMechanical aptitudeOrganizational skillsAbility to deliver information in an objective manner while influencing outcomes.Demonstrates effective communication skills in both written and verbal form.Demonstrates strong interpersonal and conflict management skills.
Validation Specialist IBS (hard science)Pharmaceutical, FDA regulated industry, and validation preferred
Validation Specialist IIBS (hard science)2 years validation experience (no experience with MS)Pharmaceutical, FDA regulated industry, and validation preferred
Sr. Validation SpecialistBS (hard science)5 years validation experience (3 years with MS)Pharmaceutical and FDA regulated industry preferred
Shift:
Days
Compensation:
The salary range for this position is $67,725 - $138,000 depending on experience.
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
Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today!Jubilant HollisterStier is an EEO/AA Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If you require assistance applying for a position, please contact our HR Department at:Human.Resources@jubl
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:
Validation Specialist IThe primary function of the Validation Specialist is to participate on project teams that are responsible for the installation and upgrade of critical systems and equipment used in the manufacturing of pharmaceutical products.
Validation Specialist IIThe Validation Specialist II serves on project teams in support of capital, compliance, and contract projects while demonstrating technical validation expertise. The Validation Specialist II also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards. The Validation Specialist II also mentors less experienced Validation Associates and Specialists.
Sr. Validation SpecialistThe Sr. Validation Specialist serves on project teams in support of complex capital, compliance, and contract projects while demonstrating expert technical validation expertise. The Sr. Validation Specialist also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards. The Sr. Validation Specialist also mentors less experienced Validation Associates and Specialists.
Responsibilities, Validation Specialist I:Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors equipment requalification reports to provide documented evidence of equipment requalifications.Under the guidance of experienced validation personnel, authors SOPs for requalification of new equipment. Revises validation SOPs to ensure correct and up to date information and processes are followed.Developing a working and theoretical 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.Initiates deviations within the EQMS system. Assist with RCA and impact assessments. Completes minor deviations. Under the guidance of experienced validation personnel, authors change controls and CAPAs.Under the guidance of experienced validation personnel, authors validation protocols and reports in support of validation projects.Developing a working knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach.
Responsibilities, Validation Specialist II:Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors equipment requalification reports to provide documented evidence of equipment requalifications.Authors SOPs for requalification of new equipment. Revises validation SOPs to ensure correct and up to date information and processes are followed.Demonstrates a working and theoretical 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.Initiates deviations within the EQMS system. Assist with RCA and impact assessments. Completes minor deviations. Authors change controls and CAPAs.Authors validation protocols and reports in support of validation projects.Demonstrates a working knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach.
Responsibilities, Sr. Validation Specialist:Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed.Authors equipment requalification reports to provide documented evidence of equipment requalifications.Authors SOPs for requalification of new equipment. Revises validation SOPs to ensure correct and up to date information and processes are followed. Approves SOPs as a department approver.Demonstrates an expert working and theoretical 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.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.Authors validation protocols and reports, developing validation strategies for complex validation projects.Demonstrates an expert knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach.
Qualifications:Proficiency in standard business computer applications (i.e. Microsoft Outlook, Word, Excel, PowerPoint, etc.).Proficiency with EQMS, LMS, and EDMS.Technical writingMechanical aptitudeOrganizational skillsAbility to deliver information in an objective manner while influencing outcomes.Demonstrates effective communication skills in both written and verbal form.Demonstrates strong interpersonal and conflict management skills.
Validation Specialist IBS (hard science)Pharmaceutical, FDA regulated industry, and validation preferred
Validation Specialist IIBS (hard science)2 years validation experience (no experience with MS)Pharmaceutical, FDA regulated industry, and validation preferred
Sr. Validation SpecialistBS (hard science)5 years validation experience (3 years with MS)Pharmaceutical and FDA regulated industry preferred
Shift:
Days
Compensation:
The salary range for this position is $67,725 - $138,000 depending on experience.
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
Unlock your potential with Jubilant HollisterStier! If you’re seeking a dynamic and rewarding career, we welcome your application today!Jubilant HollisterStier is an EEO/AA Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If you require assistance applying for a position, please contact our HR Department at:Human.Resources@jubl