Overview
On Site
BASED ON EXPERIENCE
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
VALIDATION SPECIALIST
VALIDATION ENGINEER
VALIDATION ANALYST
DIGITAL VALIDATION
COMPUTER SYSTEM VALIDATION
CSV ENGINEER
SYSTEM VALIDATION EXPERT
VALGENESIS
MASTER DATA
DATA MIGRATION
DATA INTEGRITY
DOCUMENTATION
TEMPLATES
PHARMACEUTICAL
BIOTECHNOLOGY
BIOTECH
GMP
REGULATED MANUFACTURING
VALIDATION METHODOLOGIES
RISK ASSESSMENT
TEST PROTOCOLS
QUALIFICATION
Job Details
/n/nDigital Validation Solution Expert (ValGenesis) (Validation Master Data Manager and
User Support)
At Roche, we believe it s critical to deliver medical solutions now even as we develop
innovations for the future. We are passionate about transforming patients lives and we
are fearless in both decision and action. And we believe that good business means a
better world. That is why we come to work each day. We commit ourselves to scientific
rigour, unassailable ethics, and access to medical innovations for all. We do this today to
build a better tomorrow. You ll be working within the Manufacturing Science &
Technology (MSAT) and Global Engineering group. As a key strategic enabling function
for the Roche Manufacturing network, we support the changing product mix, new
modalities and investments for our internal manufacturing capabilities and assets that
ultimately bring the Roche pipeline to commercial production to deliver for patients.
Description
The Digital Validation Solution Expert (ValGenesis)(Validation Master Data Manager and
User Support) is a vital member of our Global MSAT & Engineering team (PTT)
responsible for maintaining and updating the master data in a centralized paperless
validation system at Roche and to provide critical user support within the Roche
network. This role involves managing templates and ensuring standardization in our
validation system, as well as handling data migration tasks, process change requests,
and ensuring accurate record-keeping.
This position requires a strong understanding of the Qualification and Validation
business processes, an innovative and problem solving mindset along with a strong
ability to work collaboratively with interfaces to Global and Local MSAT, Engineering,
Quality and IT organizations.
Key Responsibilities:
Maintain accurate and organized system validation documentation standards,
ensuring it complies with regulatory requirements and company policies.
Collaborate with cross-functional teams, including Quality, Manufacturing, and
Engineering, to ensure successful validation systems and qualification activities.
Investigate and resolve challenging validation issues by applying scientific and
engineering principles, and implement corrective actions as needed.
Collaboration with suppliers to troubleshoot existing issues, test/deploy new
features and support new module Master data build.
Work closely with validation and qualification SPOCs, SMEs and Site Business
Process Managers in order to get the aligned business process translated into the
form of Master Data and enable Communications to the sites for system adoption.
Responsible for implementation (as applicable) of changes to the master data, not
only from a Specification perspective but into the ValGenesis Software for
implementation.
Manage templates upload and binding to the Content types at all the sites in
addition to template revisions
Qualifications:
Familiarity with the Valgenesis Validation Lifecycle Management System is
required.
3-5 years work experience in the pharmaceutical or biotechnology industry with
process development, operations/manufacturing, or related experience.
Proficiency in validation methodologies, risk assessments, and related
documentation.
Experience resolving issues with a variety of project documentation, including
business and functional requirements, validation test protocols and technical
support documentation.
Excellent interpersonal and collaboration skills: proven track record of building
strong and sustainable relationships with internal and external
partners/stakeholders.
Ability to act as a coach for colleagues with less experience, provide guidance,
motivates, and influences other colleagues.
Demonstrated capability to role model and actively develop effective risk taking
and decision making to colleagues with less experience and helps develop
skills/expertise.
Proven capability to foresee and solve problems through Identification of
med/high opportunities and solutions implementation.
Excellent communication and presentation skills: exhibits professional maturity,
confidence and competence.Strong executive presence and resonant
communications at all levels - experience framing communications to fit the
audience.
Ability to synthesize and summarize complex issues and conclusions so as to
expedite agreements and decision-making.
Attention to detail and commitment to maintaining data accuracy and integrity.
Exhibits strong accountability behaviors and is able to manage multiple priorities
and remain on track with objectives independently within complex environments.
Self-starter who actively manages commitments and deliverables without
direction and exercises wide latitude in how they approach their work.
Travel Requirements:
No travel required.
Relocation benefits will not be available for this role.
Other Requirements:
The ideal candidate will be located within the Eastern Time Zone to support
global projects.
Working Model: Remote
Must have: ValGenesis Experience
User Support)
At Roche, we believe it s critical to deliver medical solutions now even as we develop
innovations for the future. We are passionate about transforming patients lives and we
are fearless in both decision and action. And we believe that good business means a
better world. That is why we come to work each day. We commit ourselves to scientific
rigour, unassailable ethics, and access to medical innovations for all. We do this today to
build a better tomorrow. You ll be working within the Manufacturing Science &
Technology (MSAT) and Global Engineering group. As a key strategic enabling function
for the Roche Manufacturing network, we support the changing product mix, new
modalities and investments for our internal manufacturing capabilities and assets that
ultimately bring the Roche pipeline to commercial production to deliver for patients.
Description
The Digital Validation Solution Expert (ValGenesis)(Validation Master Data Manager and
User Support) is a vital member of our Global MSAT & Engineering team (PTT)
responsible for maintaining and updating the master data in a centralized paperless
validation system at Roche and to provide critical user support within the Roche
network. This role involves managing templates and ensuring standardization in our
validation system, as well as handling data migration tasks, process change requests,
and ensuring accurate record-keeping.
This position requires a strong understanding of the Qualification and Validation
business processes, an innovative and problem solving mindset along with a strong
ability to work collaboratively with interfaces to Global and Local MSAT, Engineering,
Quality and IT organizations.
Key Responsibilities:
Maintain accurate and organized system validation documentation standards,
ensuring it complies with regulatory requirements and company policies.
Collaborate with cross-functional teams, including Quality, Manufacturing, and
Engineering, to ensure successful validation systems and qualification activities.
Investigate and resolve challenging validation issues by applying scientific and
engineering principles, and implement corrective actions as needed.
Collaboration with suppliers to troubleshoot existing issues, test/deploy new
features and support new module Master data build.
Work closely with validation and qualification SPOCs, SMEs and Site Business
Process Managers in order to get the aligned business process translated into the
form of Master Data and enable Communications to the sites for system adoption.
Responsible for implementation (as applicable) of changes to the master data, not
only from a Specification perspective but into the ValGenesis Software for
implementation.
Manage templates upload and binding to the Content types at all the sites in
addition to template revisions
Qualifications:
Familiarity with the Valgenesis Validation Lifecycle Management System is
required.
3-5 years work experience in the pharmaceutical or biotechnology industry with
process development, operations/manufacturing, or related experience.
Proficiency in validation methodologies, risk assessments, and related
documentation.
Experience resolving issues with a variety of project documentation, including
business and functional requirements, validation test protocols and technical
support documentation.
Excellent interpersonal and collaboration skills: proven track record of building
strong and sustainable relationships with internal and external
partners/stakeholders.
Ability to act as a coach for colleagues with less experience, provide guidance,
motivates, and influences other colleagues.
Demonstrated capability to role model and actively develop effective risk taking
and decision making to colleagues with less experience and helps develop
skills/expertise.
Proven capability to foresee and solve problems through Identification of
med/high opportunities and solutions implementation.
Excellent communication and presentation skills: exhibits professional maturity,
confidence and competence.Strong executive presence and resonant
communications at all levels - experience framing communications to fit the
audience.
Ability to synthesize and summarize complex issues and conclusions so as to
expedite agreements and decision-making.
Attention to detail and commitment to maintaining data accuracy and integrity.
Exhibits strong accountability behaviors and is able to manage multiple priorities
and remain on track with objectives independently within complex environments.
Self-starter who actively manages commitments and deliverables without
direction and exercises wide latitude in how they approach their work.
Travel Requirements:
No travel required.
Relocation benefits will not be available for this role.
Other Requirements:
The ideal candidate will be located within the Eastern Time Zone to support
global projects.
Working Model: Remote
Must have: ValGenesis Experience
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.