CS Validation Analyst – Biotech (JPK1001)
Santa Monica, Ca, 90404
6 months with likely extension
3Key Consulting Inc. is looking for CS Validation Analyst for a global, CA-based, bio-pharmaceutical company.
We are seeking a highly motivated individual with 5+ years’ experience in Computer System Validation who will interface and build strong partnerships with IT, Validation, Engineering, Manufacturing, R&D and other parts of the organization. This role will manage Computer System Validation projects and assume ownership of this process, to ensure compliance with the respective procedures and regulatory guidelines as well provide guidance and support to site validation groups tasked with implementation of automated equipment and local systems.
Responsibilities (include, but are not limited to):
- Oversee computer system validation
- Manage team of Computer System Validation subject matter experts in QE department
- Support drive of integrated validation program
- Support the change control process for validated systems.
- Ensure alignment of automation system qualification at sites with CSV procedures.
- Drive computer system compliance aspects across the company project portfolio.
- Partner with peers in the QE department around automation strategies.
- Support regulatory inspections and audits.
- Establish and manage risk assessment process for computer system validation.
- Support vendor qualification and – compliance audits.
- Review technical/investigation reports as appropriate.
- Review and approve proposed changes to systems and procedures, as appropriate.
- Track, review and report metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as required.
- Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).
- Automation, equipment and utility IQ/OQ/PQ/PV.
- Department or team management/leadership experience.
Quality Assurance, GMPs, Health Authority Regulations and Validation
- Strong knowledge of GMP, GAMP, SOPs and quality systems.
- Experience with internal and external audit principals.
- Strong knowledge of change control practices/strategies.
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong written and verbal communication skills.
- Ability to communicate and work independently with scientific/technical personnel.
Bachelor’s degree in technical discipline (Computer Science/Engineering or similar).
Minimum of 10 years of Computer System Validation experience in a GMP environment (Drug Substance or Drug Product).
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
Experience in the medical and/or pharmaceutical industry.
ASQ, Black Belt/Green Belt certifications.
Top Must Have Skill Sets:
- 4+ years of CS Validation experience – preferably in GMP environment, Biotech/Pharmaceutical
- Experience with Oracle ERP suite or similar ERP systems
- Able to plan, manage, and coordinate validation activities.
- Performed Risk Based Validation for COTS, Configured and Customized software systems.
- Expert in authoring and delivering validation documents during different phases of the Software Development Life Cycle (SDLC).
- Quick learner, able to use new tools and can start on projects and hit the ground running.
- Adaptable individual with excellent problem solving and communication skills who takes ownership of all assignments and areas of responsibility.
- No CS Validation experience
- Not able to clearly and articulately support all listed skills and experience on resume.
Phone interview then in person interview.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.