Our client a well-known Boston area-based Pharma CDMO seeks a Director of Engineering & Maintenance to manage a team of 12 people in a facility of 170 employees. Additionally, this person will be responsible for capital expansion of the facility.
Company provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Director, Engineering and Maintenance oversees all manufacturing engineering operations to support manufacturing and quality in full compliance with GMP and other regulations; oversees design specification, contract negotiation, timelines and execution of numerous projects to enhance and maintain facility; optimizes the deployment of internal talent and utilization of contractors; promotes safety, compliance, best practices, engineering standards and resource optimization. This individual is responsible for being a champion for a safe work environment and developing objectives that improve the safety culture within their team and the site.
- Attend Senior Staff meetings to develop and drive initiatives for achieving company goals
- Give presentations to prospective clients on our process engineering capabilities
- Review client audit findings and implement corrective action where applicable
- Ensure project milestones are met and monthly deliverables are achieved
- Attend all project kick off meetings to appropriately set client expectations and ensure standardized approaches to tech transfer
- Reviews and approves validation protocols and final reports for client specific equipment and aseptic processing
- Ensures on-going process capability improvement
- Participates in self-development activities and training
- Establish and maintain systems to track department deliverables and trend performance against metrics
- Ensure unit’s compliance with GMP and all its related elements such as documentation (SOP’s and validation protocols, )
- Complete annual performance appraisal for direct reports
- Develop weekly/monthly goals and manages activities through direct reports
- Bachelor’s Degree in Engineering or related discipline
- 10+ years of experience pharmaceutical/biotechnology industry; experience in a cGMP/FDA regulated environment required
- Current in cGMP’s and how to implement management systems that promote cGMP compliance
- Knowledge of cleanroom process flows and process design; this could include: biodisposable strategies, sterile filtration, mixing strategies, fluid transfer to and from various compounding vessels/biobags
- Specialty knowledge of UF/DF, liposomal compounding/formulation strategies (ethanolic injection, extrusion), high shear mixing strategies, emulsions, suspensions, micronization techniques
- Experience with clean room personnel, material flows, and aseptic processing regulatory requirements