Validation SME - Delivery Leader

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

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.
• 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 of appropriate industry guidance and regulatory requirements; Intermediate to expert skills with WORD, EXCEL and PROJECT; Excellent English communication skills (written and verbal); Calm and collected leader with the ability to guide a team in stressful client services-oriented projects; Understanding of laboratory and automation manufacturing and assembly equipment (PLCs, HMIs, PC based controls); Understanding of enterprise level systems commonly used in pharma/biotech companies; Highly proficient in authoring/executing validation documents for equipment/ facilities/ utilities
• Supervisory Requirements: This position will be responsible for project management of employees and contractors working on projects in your portfolio. This is not a Verista internal management position and as such will not assume direct management oversight for FTE employees from a growth and development perspective. This position is responsible for collaboration with Verista employee’s direct managers to provide feedback and performance support. This position is responsible for the direct management of all contractors working on assigned projects per contractual terms.

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance
• Medical, Dental