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Charles River Laboratories
Wayne
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your ski
Job Source: Charles River LaboratoriesCharles River Laboratories
Wayne, PA, United States
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your ski
Job Source: Charles River LaboratoriesCharles River Laboratories
Wayne, PA, United States
Manage computerized system validation activities in CRL Manufacturing Operations, ensuring compliance and quality in equipment and software. Responsible for documentation maintenance and serving as a resource for validation team members, contractors, and vendors. Responsibilities: Lead full lifecycle of validation projects, delivering on time and
Job Source: Charles River LaboratoriesBayer (Schweiz) AG
, PA, United States
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabil
Job Source: Bayer (Schweiz) AGSK pharmteco
King of Prussia, PA, United States
Position: CSV Engineer (Level II and Level IV/Sr) Location: King of Prussia (onsite) Company: SK Pharmteco The Computer System Validation (CSV) Engineer will be responsible for executing validation activities for computer systems and software applications, ensuring compliance with regulatory requirements, industry standards, and company polic
Job Source: SK pharmtecoOmni Inclusive
King of Prussia, PA, United States
JD- Keywords CSV, Computer System Validation, SAP Validation, Product Serialization, DSCSA Roles and Responsibilities 10 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure
Job Source: Omni InclusiveProject Farma
Philadelphia, PA, United States
This role can involve up to 100% Travel Why Precision for Medicine? Welcome to the forefront of innovation in cutting edge patient treatments. We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and
Job Source: Project FarmaTransPerfect
Philadelphia, PA, United States
TransPerfect Is More Than Just a Job… Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that. Each of our 100+ offices has its own individual identity, and each also has its own unique rewards. Compensation Starting at: $63k Benefits: Company benefits – If applicable Who We Are: Tr
Job Source: TransPerfectPhiladelphia, PA, United States
Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.
Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.
What You’ll Do
As a Computer Systems Validation (CSV) Consultant at Clarkston you will:
Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device, and other GxP and GAMP regulated environments
Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications
Engage your clients and teammates in value-add relationships to deliver outstanding project outcomes and identifying new opportunities to serve your clients
Share best practices, industry knowledge, and personal expertise to educate both clients and fellow consultants, in formal and ad hoc settings
Continually update your own knowledge base and that of your teammates by participating in educational and networking opportunities
How You’ll Grow
Beyond your day-to-day responsibilities, throughout your career at Clarkston you will:
Receive the support and mentorship of your Clarkston colleagues and leaders
Expand your existing skillset with internal and external professional development opportunities
What We’re Looking For:
Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
Experience with systems including (but not limited to) on-premise and cloud solutions such as SAP, Veeva, LIMS, Documentum, Trackwise, Empower, MES, Serialization solutions; as well as networks/infrastructure and hardware qualification
Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management considering computer software assurance (CSA) principles
Professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device and other GxP and GAMP regulated environments
Experience with Data Integrity impacts on Validations including Audit Trail Risk Assessment
Flexibility and adaptability - our Consultants work on the full validation lifecycle in oversight and hands-on roles, and can stretch into new roles when asked
Bachelor's or 4-year degree from an accredited college or university
Travel Requirement
Travel is an integral part of this role and is estimated to average 30-50%. This may vary based upon client and project needs. When not traveling, consultants work from their home office. Relocation is not required.
More About Clarkston
Founded in 1991, Clarkston Consulting delivers technology and management solutions to market leaders in the life sciences, consumer products, and retail industries. At Clarkston, we cultivate success - for our clients, for our people, and for our firm. We utilize a team approach leveraging our collective expertise and industry knowledge to solve our clients’ business challenges.
Our benefits include:
Comprehensive Health and Wellness Benefits (Medical, Dental, Vision, and more)
401k with company contributions
Paid vacation, personal days, holidays, and sick leave
Paid Parental Leave and Family Building Benefits (Adoption, Surrogacy, and Infertility Support)
Life and Disability Insurance
Training and Professional Development investments, Tuition Assistance, and more
Visit Careers at Clarkston to learn more about our culture, benefits, and opportunities.
Clarkston Consulting is an equal opportunity employer. We are committed to ensuring our firm is rich in diverse skills, competencies, strengths, personalities, and culture. We foster an inclusive environment that embraces the unique contributions of our people to further our purpose. Please visit Diversity @ Clarkston to learn more about our diversity initiatives.
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Email Alert for Computer Systems Validation (CSV) Consultant jobs in Philadelphia, PA, United States
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