SR SME Consultant Medical Affairs BIS Operations Lead - 3931C

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Verista is currently seeking Validation Engineers with experience in facilities, equipment and process validation within a pharmaceutical or biotechnology manufacturing environment to support CQV (Commissioning, Qualification & Validation) activities.

Requirements

Will work remote primarily but would like to meet in person in Boston office at times

SME Consultant Responsibilities:

Working with Global Medical Affairs BIS Director
• Manage day to day operational requests for Global Med Affairs systems in the following functions: Field Medical, Scientific Communications, Medical Information, and Cross-Functional

For system enhancements, operations and defect requests – gather requirements, enter tickets for technical team, conduct UAT (in partnership w/ business stakeholders as needed) and communicate status. Escalate and get guidance on strategy and approach from MA BIS Director as needed.• Manage timeline and meetings needed to move operational requests forward - including input from business and vendors.
• Work with Service Desk partner to transition account provisioning and decommissioning of all Med Affairs systems to Service Desk
• Increased satisfaction by the Medical Affair business stakeholders on day-to-day operations of tools

Opportunity to also PM specific Medical Affairs BIS projects, as operations piece is established
Looking for someone with experience in Medical Affairs and/or experience in the following tools:
• Field Tools:
•Veeva CRM
• Scientific Communications
• Datavision (or other publications management workflow tools)
• MedInfo

Mavens Medical Information Cloud (or other MedInfo systems)
• Docuvera
• Cross-functional

• Veeva Vault (MedComms)
• MediSpend for IMEs and ESRs (or other Grants management tools)
• Tableau reporting – data and analytics

You will have:

• This position requires a minimum of a Bachelor’s degree in an Engineering or Scientific degree.
• Experience in GMP regulated environment commensurate with Job Level Differentiators defined below.
• Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls).
• Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
• Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
  • Good Documentation Practice (GDP) in pharmaceutical environment
  • ASTM-E2500
  • ISO 14971 – risk management for medical devices
  • ISPE Applied Risk Management for C&Q
  • ISPE Science and Risk Based Approach for the delivery of facilities, systems, and equipment
  • ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools
  • 21 CFR Part 2XX and 8XX level regulations and interpretation as applied in the above standards.
• Experience and knowledge of mechanical systems and clean utilities including ability to read electrical, mechanical, P&ID (piping and instrument) and facility drawings

Desired Skills:

If you are qualified, have leadership potential and a willingness to learn, Verista could be the right career choice for you

Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical premiums for Employee option.
• Company paid Life, Short-Term, and Long-Term Disability insurances