Manufacturing Maintenance and Automation Specialist -Pharmaceuticals
Manufacturing Maintenance and Automation Specialist -Pharmaceuticals
Posted on :
15-03-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
15-03-2025
Job Description
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 scaleup and commercialization efforts.
- Lead root cause investigations.
- Lead lifecycle 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 drugdevice combination products.
- Contribute towards overall business strategy and annual budget process.
- Provide project updates/reporting through program governance.
- Provide leadership and support for intersite 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 semiautomated 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 lifecycle 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/PQs 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 & problemsolving skills
Thanks
Vizonere LLC
Vizonere LLC
Employment Type
Full Time
Key Skills
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