Summary:
Responsible for maintenance and engineering activities in the context of pharmaceutical manufacturing equipment. The Specialist will be responsible for clinical/commercial manufacturing equipment including semi-automated to automated and large-scale manufacturing operations. The Specialist will utilize industry standard and novel equipment, processes, and methodologies to install, repair, and maintain equipment to standards of safety, quality, and availability. The Specialist will be responsible for developing, maintaining, and optimizing calibration and PM cycles for all manufacturing equipment. The Specialist will interface with Quality, Manufacturing and R&D teams and be responsible for independently providing direction, initiation, planning, coordination, implementation, execution, control, and completion of specific maintenance and repair of departmental equipment. This is a hands-on position which requires daily tactical responsibilities leading up to strategic decisions.
Essential Duties and Responsibilities
- Provide technical leadership to the manufacturing team and management.
- Lead and execute maintenance both repair and preventative.
- Responsible for developing and implementing best practices for maintenance and service in accordance with manufacturers recommendations.
- Develop, propose, and implement vision, strategy, policies, processes, and procedures to aid and improve business performance.
- Lead scale-up and commercialization efforts.
- Lead root cause investigations.
- Lead life-cycle management efforts.
- Lead and execute technical analyses including statistical analysis and tolerance analysis.
- Document studies and author documents per US FDA, EMA, MHRA and other global health authority requirements.
- Interface and lead activities with third party contract research, development, and manufacturing organizations.
- Ensure that manufacturing strategies and processes are in place to meet business objectives and operational needs in terms of price, quality, and delivery targets and that enable the organization to function and compete effectively in the market.
- Proactively evaluate the challenges faced by the business and take actions to mitigate risks and develop opportunities.
- Contribute towards and maintain device design history files (DHF).
- Document standard operating procedures (SOPs) for design controls and manufacturing in the context of pharmaceutical drug-device combination products.
- Contribute towards overall business strategy and annual budget process.
- Provide project updates/reporting through program governance.
- Provide leadership and support for inter-site best practices (technology transfer, process validation, etc.) and phase appropriate guidelines and policies.
- Execute project strategy, priorities, and milestones ensuring visibility and accountability.
- Proactively lead with integrity and engage cross functional project teams and stakeholders.
- Support organizational / departmental initiatives.
- Prepare and conduct presentations to all levels of the organization which may include project technical and budgetary information.
Qualification Requirements
- A B.S, in Mechanical Engineering, Electrical Engineering, Robotics or related discipline with 5 to 7 years, A.S. with 7 to 10 years’ experience in pharmaceutical or related field.
- Experience with cGMP manufacturing in the context of pharmaceutical clinical and commercial manufacturing is a must to have.
- Must possess expert knowledge and experience with manufacturing and aseptic filling processes including manual, semi-automated and/or commercial scale automated processes.
- Experience with ComapctLogix (PLC); AVEA (formerly Wonderware); Windows 10 Enterprise IoT LTSB; PMS (Particle Monitoring Systems) software packages is highly preferred.
- Experience w/ Staubli robots is preferred.
- Proven automation experience with increased levels of responsibility
- Knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical sector.
- Must possess knowledge of various pharmaceutical processing equipment design, optimization, qualification, and life-cycle management.
- Must possess knowledge of regulations and standards including US 21 CFR Part 820, 821
- Experience with DCS and/or PLC software design.
- Experience in development of orally inhaled and nasal drug products (OINDPs) is a plus.
- Experience with IO/OQ/PQ’s is a plus.
- Experience with FAT/SAT is a plus.
- Strong English language skills including writing ability and oral communication.
- Demonstrates good judgment as well as cultural, social, and environmental awareness.
- Trade background would be an advantage
- Good analytical & problem-solving skills
