- Define construction materials, operating principles, and testing performance characteristics for utilities and equipment. Ensure that utilities and equipment are built and installed in compliance with the design specifications and all applicable building codes.
- Ensure that construction meets the principles of reliability, availability, maintainability, and safety.
- Comply with current Good Manufacturing Practices.
- Work closely with engineers and architects to develop plans, establish timetables, and determine labor and material costs
- Ensure that all drawings and specifications are examined, prior to beginning construction, for design deficiencies, impractical details and possible code violations, and through a meeting with the Architect, bring them to a resolution
- Manage and direct outside vendors and contractors working on project team
- Manage subcontractors and employees, gather permits, and ensure all aspects of the project are up to code
- Overall project planning, distributing resources, time management, risk management, creating benchmarks, managing the budget, managing staff, and managing relationships with key stakeholders.
- Ensure construction project is compliant with current building codes as well as any other legal or regulatory requirements
- Creating benchmarks and measuring
- Time management maintain, evaluate, and readjust a schedule as necessary to meet deadlines
- Maintain Regular Project Reports and journals
- Communicate the progress and health of the project with key stakeholders and management
- Provide planning, consultation, advisement, and knowledge captured
- Manage project budgets by maintaining statistical and financial records, keep track of spending and forecast changes to the budget
- Supervise engineering and technical staff participating on project teams
- Purchase and install new equipment
- Arrange and lead in the overhauling of existing equipment
- Investigate building system problems to diagnose to root cause and recommend lasting solutions
- Make continuous improvements to current systems and operations to enhance efficiency
- plan and organize maintenance activities
- Commission new equipment using well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the Production Department that results in a safe and functional environment that meets established design requirements and stakeholder expectations
- Manage Risk, identifying and responding to potential issues throughout the life of the project to minimize potential negative impacts and help ensure the safety create a contingency plan to have a proactive approach
- Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations
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What Aptar Pharma Is Looking For:
- BS in Mechanical Engineering Industrial Engineering or Electrical Engineering
- At least 2 years of experience in Medical Device Manufacturing, Pharmaceutical, or FDA regulated environment in Facilities related roles
- Knowledge and experience operating under OSHA standards
- Knowledge of or trained in Lean Manufacturing / Six Sigma
- At least 5 years of experience with third-party vendors, contractors and service providers required
- Demonstrated experience managing a biotech facility, including a combination of manufacturing, research, and office space. Experience scaling operations and building new space is preferred.
- Strong project management and organizational skills
- Knowledge of and experience with:
- TAB – Testing Adjusting Balancing Air
- HVAC and HVAC Controls BMS and DDC
- Air Balancing
Industrial Operations
- Maintenance Operations
- OEE – Overall Equipment Efficiency
- Electrical, plumbing, carpentry, compressor
- Utilizing SAP and MS Office.
- Thorough understanding of cleanrooms and cGMP.
- Ability to read blue prints/schematics and to use shop tools
- Results driven! Hands-on, roll-up-your-sleeves approach with high sense of urgency
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- Excellent communication and inter-personal skills. Proven experience with diplomacy with all stakeholders and the ability to build strong relationships
- Detail oriented, rigorous, analytical, reactive, and good interpersonal skills.
- Executing PFMEA/FAT/SAT/IQ/OQ/PQ
- Generate technical documentation for Maintenance Operations such as work instructions for production processes
- Train staff Supervise operator training
- Ability to travel to Site locations in Europe
Aptar Pharma, NA
250 Route 303 North
Congers, NY 10920
www.aptar.com
Create, Innovate, Deliver Solutions!
Aptar is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information
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