Responsibilities may include:
- Establishes and communicates a clear vision for a fully integrated and high performing automation team that is aligned with the strategic objectives and business goals for QuVa Pharma
- Ensures effective and compliance operations in accordance with site registrations, GMPS and environmental regulations and state requirements
- Effectively develops and leads the QuVa Pharma automation specialists to provide site services with accountability for support of automation of production equipment, site capital projects, process control automation and SAT/IOQ Execution for new facilities and equipment, to enable the QuVa Pharma operations and other support functions to meet or exceed business expectations in cost, quality, compliance, safety, culture and capital
- Leads or participate in design of facilities and semi-automated or automated processing equipment, oversees execution of commissioning and qualification activities
- Defines and implements necessary automation improvements within the new/existing Bloomsbury operations to maintain current GMP and Industry Best practices; as well as drive industry standards with regards to 503B outsourcing manufacturing facilities through participation and engagement with regulators, industry subject- matter experts on automation, knowledge and principles from other related industry segments that utilize controlled environments and aseptic manufacturing
- Stays current with industry trends and identifies opportunities for workforce development and continued education for staff
- Effectively executes projects that improve quality, safety, product cost, risk reduction and plant capabilities. This includes the development and preparation of required cGMP documentation required for the engineering and projects as well as the ongoing facility, equipment, and maintenance programs. Assures completion of all phases a project in a timely and efficient manner
- Networks and partners effectively internally with cross-functional disciplines (Procurement, Technical Support, Manufacturing, Quality, Finance, IT, HR) as well as externally with customers, suppliers, and regulators to ensure compliance with company policies, procedures, and regulatory requirements, as well as promote an organizational culture that supports the achievement of business objectives
- Develops direct reports and builds a high-performance team through utilization of a performance management process that sets expectations, ensures ongoing coaching/mentoring, and assesses employee performance
- Supports development of site and departmental metrics to gauge ongoing performance of organization and identification of opportunities for continual process improvement’
- Other duties as assigned
Desired Skills and Experience
Experience
- 20,000 CFM Exhaust Systems
- 20,000 + CFM Air Handlers
- Direct experience working on large scale mechanical systems (HVAC)
- 3 years of experience managing a team specializing in pharmaceutical environment as well as experience in the facility and utility standards for the pharmaceutical industry is required
- Bachelor of Science in Engineering related field, or equivalent Science or Manufacturing Management related field, or a combination of education and industry experience
- Legally authorized to work in the job posting country
- Experience with pharmaceutical equipment
Education
- Bachelors or better in Engineering or related field.
