VTI Life Sciences(VTI) is a highly successful and growing Biopharmaceutical consulting company. We are looking for a Senior Computer System Validation Engineer to work with our various clients in the Greater Boston, MA area.
VTI is a recognized industry leader that provides our clients in the FDA regulated Life Science industries with integrated project teams to deliver effective commissioning and qualification of facilities, equipment, and automated systems, as well as validation of processes. VTI combines extensive knowledge and experience of the industry, as well as our in-depth understanding of the regulatory FDA/EMEA risk based management approach to provide added value for our clients both within the US and globally.
Responsibilities include, but are not limited to, the following:
• Plan, lead, and execute computer system validation projects.
• Work with limited direction. Direct and manage onsite CSV team.
• Assist with coordination of field activities.
• Serve as SME for 21 CFR Part 11, CSV, and IT Compliance applicable to GMP environments.
• Work with limited direction. Provide guidance and coordinate work activities with other personnel.
• Capable of authoring Computer System Quality and Validation Policies, Standards and practices (as the leader of the onsite CSV team).
• Plan, implement, and coordinate commissioning and qualification of computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
• Author and execute commissioning and qualification of CSV documents through system life cycle. This includes deliverables such as user requirements, design specifications, qualification protocols, reporting, and support documentation (i.e. traceability matrices, SOP, etc.).
• Demonstrate good interpersonal skills including the ability to interact well with a variety of personalities, craft skills and educational levels.
• Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11 following GAMP concepts.
• Must have profound knowledge of the FDA, EMEA and International regulations regarding Computer Systems.
• In depth knowledge of IT to be able to interact with client IT leadership in highly technical language.
• Knowledgeable of FDA, GxP, EMEA and International related regulations and guidelines such as GAMP and ICH and ISO. Specific knowledge of computer validation methodologies and principles is a must
• Knowledge of CSV requirements and procedures for laboratory instrumentation and instrument qualification (IQ/OQ/PQ).
• Working, hands-on, knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
• Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter.
• Must have strong leadership, negotiation and presentation skills.
• Capable of providing training on current CSV regulations and mentorship to team members.
• Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.
• Must have a minimum of a Bachelor's degree (or equivalent) in Computer Science, Engineering Science, or other related degree concentration with 10+ years of experience in the Pharmaceutical or Biotech industry . • Experience with the management of a team is preferred.
VTI strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics, Medical Devices and Life Sciences industries. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
We offer professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating a collaborative work environment. As one of the leading global Validation Services firms, VTI is always looking for innovative, talented and experienced validation professionals for our Multi-national and global offices. www.validation.org