Validation SME - Delivery Leader

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.

Responsibilities

Manage, execute and lead designated staff on projects to ensure customers, sales and service delivery activities meet or exceed goals; Carry utilization targets on billable projects as a high-level or recognized market SME (50-75% range); Manage and track annual goals including Revenue, Margin, Utilization, Employee Retention, and Client Rating; Develop strategies and tactics to ensure goals are met and update monthly goal reports; Support lead generation activities and review, assess, and define requirements for scope and estimation of contracts; Support new business development with new logo and existing accounts during the sales process; Ensure all services projects conform to organization's and customer's policies and objectives; Accountable for solutioning/delivery methodologies including evolution to managed service offerings; Ensure standards and consistency with employees and clients; Accountable for accuracy of Salesforce Resource Planner; Manage assigned staff utilization, resourcing, and forecasting; Communicate staffing needs to HR/TA and interview prospective candidates; Support performance review process and provide project-related feedback; Directly manage contractors on projects including onboarding/offboarding and performance; Hold employees accountable and provide feedback; Build a team environment with high morale and provide input on marketing, website, and growth strategies

Requirements

Bachelor’s degree in a technical (STEM) discipline; 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), ASTM-E2500, ISO 14971, ISPE Applied Risk Management for C&Q, ISPE Science and Risk Based Approach, ICH 8/9/10; 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 in a fast paced, high growth, results driven organization; Experience in Project Management managing 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; Proven experience and aptitude to meet, interact, and present in front of a wide range of customers including C-level executives, project managers, plant engineers, supervisors, operators; Ability to strategically negotiate with clients and employees in high stress situations; Strong leadership, deep practical validation knowledge, and proven track record for timely project delivery, project management, cost control, and customer satisfaction; 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/editing/executing validation documents for equipment/facilities/utilities

Nice to have

Validation program management; validation master planning experience

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 & Vision insurances; FSA, DCARE, Commuter Benefits; Supplemental Life, Hospital, Critical Illness and Legal Insurance; Health Savings Account; 401(k) Retirement Plan with Employer Matching; Paid Time Off (Rollover Option) and Holidays; As Needed Sick Time; Tuition Reimbursement; Team Social Activities; Employee Recognition; Employee Referral Program; Paid Parental Leave and Bereavement