Engineering Manager
Nashville, Tennessee
Operations – Facilities & Engineering /
Full-Time /
On-site
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
The Manager of Engineering is accountable for managing all Engineering responsibilities for non-GMP / GMP Site activities at August Bioservices Nashville, TN manufacturing site. The site consists of office space, laboratory facilities, central utilities, warehouses, drug product filling, manufacturing, and all support infrastructure and equipment. This function will plan and co-ordinate daily operations to meet capital investment project strategies and the expansion of all utilities and process equipment in full compliance with Quality, Safety, and cGMP standards. This includes the management and leadership of direct staff and outsourced partnerships with contract firms. The position will direct the development of departmental workflows, workload management, guidance instructions or procedures and general technical support to cross-functional manufacturing, lab, operations, and office staff and is as such critical to ongoing operations
Responsibilities
- Provides leadership and supervision to the Engineering Department in support of Manufacturing operations and Critical Utilities. Creates goals and tracks metrics against operational goals.
- Develops, communicates, and implements tactical goals in support of Manufacturing operations and Facility utilization.
- Responsible for coaching and professional development of direct reports and staff.
- Leads from a strategic and operational perspective external service providers for site services, project work and GMP and non-GMP manufacturing support incl. contract management.
- Establishes procedures and programs to ensure safe, compliant, and reliable operations including business continuity and cGMP compliance.
- Represents the site on audits and inspections by regulatory agencies.
- Ensures and maintains strong safety record across department and strategic contract partners.
- Supports capital project investment strategy and implementation as necessary.
- Provides leadership and mentoring / development to the Engineering team.
- Supports change management activities and provides management of critical compliance metrics for quality management of engineering activities.
- Provides ownership and guidance for engineering document management including commissioning, validation support and the drawing management program.
Requirements
- A minimum of 10 years of Engineering experience in a cGMP environment
- Practical knowledge and application of cGMP and FDA, EMA regulations.
- Bachelor’s Degree in an Engineering or related field.
- Experience in developing facilities and engineering management programs for a major site.
- Demonstrated management and track record in safety.
- Experience coaching, developing, and managing a staff of professional employees as well as contractors.
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
