Two River Consulting Partners

Role Description The primary areas of focus for this role include technical delivery and business development in the Eastern region of the United States. 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. - Provide positive leadership, managing and growing service offerings by partnering with applicable service owners, sales, and client leadership. - Drive the company Values and Mission - to be the leading provider of automation and compliance solutions across the entire regulated IT-OT Stack. - Lead strategies and tactics related to ensure: - Industry Leadership - Customer Value - Expansion & Growth - Collaboration & Scale - Set an example of the company culture of hard work, positive attitude, commitment to satisfy the customer, and strong interpersonal skills. Qualifications - 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) 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. Requirements - 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 - Supervisors, 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/editing/executing validation documents for equipment/ facilities/ utilities. Benefits - This role must maintain average utilization on billable work. 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. - The Validation SME is required to sign an Employment agreement document and will be eligible for Senior Leadership Incentive programs. Work Environment - Work is most often performed at the client sites, requiring travel on a regular basis for: - Client and employee check-ins - Tech sales support - Billable consulting work - This role must reside within a daily commutable distance of the East Coast market, targeting the Boston, NJ, and RTP markets. - Typical travel is approximately 50%. Business development opportunities and tight project requirements may demand significant hours beyond 40 and hours on the weekend. Average work hours are approximately 45-50 hours/week.