Validation engineer Jobs in Lynn, MA

Validation Sme - Delivery Leader

East Coast (Multiple)

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

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

Job Function:

The primary areas of focus for this role include technical delivery and business development in the Eastern region of the United States. Verista is structured as a matrixed organization and the delivery operations partners with client services leadership and sales to manage the overall delivery and client experience collectively. The Validation SME, with Delivery Leader role, is responsible for managing and growing all revenue specific to their respective accounts and region for which they are assigned.

This role provides positive leadership, manages and grows their service offerings by partnering with applicable service owners, sales and client leadership across all their assigned accounts and projects. The Validation SME is a cross functional expert that must work with their Regional Heads and the Executive Leadership Team to develop and ensure quality execution of services, new business opportunities, talent development and packaging of services to optimize profitability.

The successful incumbent will drive the Verista Values and Mission - to be the leading provider of automation and compliance solutions across the entire regulated IT-OT (Information Technology and Operations Technology) Stack. This includes leading strategies and tactics related to ensure:

• Industry Leadership
• Customer Value
• Expansion & Growth
• Collaboration & Scale

The position is to set an example of Verista Culture of hard work, positive attitude, commitment to satisfy the customer, and strong interpersonal skills.

Job Responsibilities:

• Manage, execute and lead the designated staff on projects they are assigned to ensure customers, sales and service delivery activities meet or exceed customer and company goals and expectations
• As a technical leader in a professional services organization, this role is expected to carry utilization targets on billable projects as a high-level or recognized market SME. Targets are in the 50-75% range and will be specifically defined in alignment with overall Gross Margins targets within your assigned accounts and region. Technical knowledge and ability to connect at all levels are essential to success in this role
• Manage and track to annual goals including Revenue, Margin, Utilization, Employee Retention, & Client Rating
• Develop strategies and tactics to ensure goals are met
• Update monthly goal reports
• The Validation SME Delivery Leader's responsibilities as outlined in the corporate RACI document including but not limited to the following areas and activities:
• Sales and New Engagement Activities in the Delivery Leader Role Capacity
• Offer and support all lead generation activities, as necessary
• Responsible for reviewing, assessing and defining all requirements for scope and estimation of contracts
• New Business Development: The Validation SME Delivery Leader are responsible for providing the technical depth and supporting relationship development with new logo and existing account sales and client services members during the sales process
• Project Implementation and Execution as SME
• Ensure all services projects, initiatives, and processes are in conformance with organization's and customer's established policies and objectives
• Accountable for all solutioning/delivery methodologies including the evolution to more managed service offerings utilizing scalable fundamentals related to people, process and technology
• Focus upon ensuring standards and consistency with each and every employee and client
• Accountable for accuracy of Salesforce Resource Planner for projects and accounts assigned to you
• Employee Development and Staffing in Delivery Leader Role Capacity
• Manages all assigned staff utilization on assigned accounts/projects to optimize revenue, margin and ability to respond to project needs expeditiously
• Manage team resourcing and forecasting for assigned projects to ensure effective and appropriate staffing levels
• Clearly and effectively communicate staffing needs (positive or negative) in a timely manner to allow for effective sales
• Communicate with HR and TA about resource needs including skillset required and timing. Work with TA to recruit talent for the proper mix of Subject Matter Experts and new talent at the proper target utilization level
• Interview prospective candidates and provide hiring/offer recommendations for executive approval
• Support the performance review process for Verista FTE employees, providing project related feedback to the employees direct managers for the project you are assigned to
• Direct management of all contractors on projects at assigned accounts. This includes management of onboarding/offboarding at client sites, as well as management of their time, delivery and client interactions
• Challenge employees working at assigned accounts to do their best. Have high expectations!
• Hold employees working at assigned accounts accountable who do not meet expectations and provide feedback appropriately
• Develop and build a team environment with high morale and positive corporate culture. Provide input on marketing, website, and strategies to facilitate growth

Background Requirements

Education

Bachelor's degree in a technical (STEM) discipline

Industry Experience

• 15+ years' engineering experience in GMP regulated environment with direct experience in pharmaceutical or medical device validation
• 5+ years' professional services and consulting experience
• 5+ years' experience in professional services business development and customer relations
• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including:
• GAMP5
• 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
• In depth knowledge of process, manufacturing, and/or packaging equipment validation within Life Sciences or GMP
• CQV and CSV expertise with equipment and associated software systems
• Holistic understanding of process systems including work-processes, optimization methods, risk management, and project management
• Experience working in a fast paced, high growth, results driven organization
• Experience in Project Management; managing numerous projects ranging from $50K to in excess of $5MM
• Prior supervisory experience managing at least 20 people and at least 3-5 direct reports
• Background in internal and external CSV and CQV validation
• Sought out for knowledge of best practices in the industry for development of validation standards for pharma/biotech validation and compliance.
• Prefer validation program management and validation master planning experience

Skills

• Proven experience and aptitude to meet, interact, and present in front of a wide range of customers with varying roles including:
• C-level executives
• Project managers and plant engineers
• Supervisor, operators
• Ability to strategically negotiate with clients and employees in high stress situations to resolve
• Project and technical issues
• Funding and change order discussions
• Employee performance
• Possess a history of strong leadership, deep practical validation knowledge and a proven track record for timely project delivery, project management, cost control, and customer satisfaction.
• Demonstrated ability to provide practical, specific guidance to colleagues regarding the knowledge