Director Of Engineering
Company Name:
RHO Consulting solutions
job
Description:
Minimum Educational Qualifications required for the job: Bachelor's Degree in Mech./Electrical Engineering
Minimum years of Experience required for the job: Typically requires a minimum of 10
years in Pharmaceutical, Oral Solid Dosage
Reports to: Vice President / General
manager
Supervises: Maintenance Supervisors #4
Accountabilities:
1. Support production volume 3.5B tablets/capsules.
2. Maintaining manufacturing and packaging machines - Maintain manufacturing and packaging machines to perform at optimum performance level to meet production targets.
3. Provide engineering support for evaluation of new machines.
4. Utilities - Maintain HVAC Systems, USP Water, Boilers, Compressed Air, Hot Water and Electricity available in quality and quantity to meet production targets.
5. Facility - Maintain Three facilities total 300,000 sq. ft. approx. at all times to acceptable level of FDA, OSHA, Fire Systems and environmental agency compliance.
6. Maintenance Budget - Prepare annual maintenance budget forecast and monitoring.
7. Capital Projects - From $10,000 up to $.5M. Prepare capital project proposals in line with the requirements, implementation and timely completion.
8. Compliance - Maintain Engineering Documentation up to date to the requirements of FDA, EU, OSHA, Environmental, Local Township, Insurance Carrier, and NFPA.
9. New Product Launches - Coordinate and provide appropriate support to Product Development and Production to launch products in time.
10. Plan activities by the Engineering and Maintenance Department, supervise the execution of planned maintenance, and manage contracted
services
including; housekeeping, manufacturing, calibrations, HEPA filter testing, grounds keeping, pest control, and spare parts.
Level of Responsibility:
1. Break down and corrective Maintenance of Manufacturing, Packaging, Utility and Facility systems, providing maximum availability of machines to the users within limitations.
2. Evaluate new machine requirements, identify appropriate manufacture.
3. Provide necessary engineering support to alleviate operation technical issues, so that Product Development completes development and new product launches.
4. Project coordination: Develop scope for new project, review scope with users, hiring of designing engineers, review of drawings, obtaining bids from contractors, evaluating bids for completeness, executing construction, support validation activities as applicable, handover to the user.
5. Large Project - Recommendations, temporary facility connections, assisting temporary shut downs, providing operational sequences for utilities, security, alarms and fire suppression systems.
6. Evaluate, address and complete incomplete and any deficiencies of large projects.
7. Cost saving - Recommend management for cost saving proposals. Work with user to help complete activities needed for any cost saving projects.
8. Training - Ensure maintenance mechanics are trained. Organize training for new systems, equipment with respective contractor / supplier. Provide refresher training to mechanics. Assess individual skills and prepare development plan to address deficiencies.
9. Coordinate safety related issues, implements safety recommendations.
10. Audit - Coordinates for internal and external audits, prepares site for the audits, and provides requested information within acceptable time. Implements post audit recommendations.
Scope: OHM Laboratories Inc.US facilities (Livingston Ave, Terminal Rd, Vandyke Ave)
Dimension: Facility - 300,000 sq.ft.,Granulation suites - #14, Compression machines - # 15, Film Coating- #9, Encapsulation - #7, Bottling lines - #5, Cartoners - #4, Blister Pack, Air Handling Units - 55, Chillers - 8, Boilers - 11,Air Compressor - 6, Pumps - 48.
Financial
o Annual engineering personnel budget:$1.4 M
o Expenses:$3.5 M
o Projects - $.5 M
Staff
o Direct Reports: 4
o Indirect Reports: 35
Delegation of Responsibility: The job responsibilities can be delegated to Project Manager / Maintenance Supervisors
Job Profile:
The Engineering Director is directly responsible for providing direction and leadership to the engineering managers which execute all Engineering related activities carried out on-site (automation, capital projects, utilities, equipment, etc.). Directly responsible for the management of internal company assets, departmental personnel, external professional Engineering and other firms as part of the execution of equipment, facility or utility modification / upgrade, or expansion projects. This direct management responsibility includes all support activities and functions necessary to ensure successful completion of engineering project objectives.
Provides approval for Engineering and facility designs from the site; Manufacturing (who approve designs from a manufacturing operations perspective): Quality (who approve designs from a regulatory compliance standpoint); Ensure all facilities, utilities and/or equipment are handed over effectively to site User Departments and Maintenance personnel. Accountable for Engineering and Site Capital Project budgets; Build long-term Engineering plans; perform any other activities as required. Ensures all work carried out and equipment installed has been done safely, effectively and in compliance with the appropriate industry standards.
Ensures all company and site Engineering policies and procedures are adhered to.
Manages engineering leadership to ensure all work undertaken is reflected accurately in up-to-date Engineering, Project and Maintenance information files.
Partners with site senior management to identify the current and future engineering needs of the site. Develops and implements the strategy required and reports project status to senior management as necessary.
Provides guidance to the engineering team regarding direction and information provided to external professional Engineering firm(s), which have been engaged in the design and/or construction elements of site projects.
Manages site activities necessary for successful execution of project(s) and ensure these are completed as necessary to tie in with the overall project execution.
Manages and resolves technical issues or changes arising throughout Engineering project life cycle(s) while ensuring the overall project objectives of scope, cost and schedule are adhered to.
Ensures that all activities are in compliance with cGMP, OSHA and EPA regulatory requirements.
This
position
has direct responsibilities for Engineering support group for Calibrations, PM and Purchasing of spare parts.
Assessment and Planning of Work
Maintenance -90%
Project -75%
Technical- 45%
Areas where decision is made independently:
Maintenance - 85%
Projects - 75%
Areas where decision is made in consultation with others:
Maintenance and scheduling 15%
Projects - 15%
Areas where decision are delegated to a higher level:
Projects - 10%
Problems/ Key Features
1. Deliver critical requirements immediately
2. Arrange external help immediately
3. Advise alternate means to come out of crisis
4. Crisis management
Interface:
Internal - Production, QC, Warehouse, Purchasing and Planning
External - Contractors, suppliers and regulatory bodies.
Competencies Required:
Technical Competencies
1. Machine repairs
2. Alternate sourcing
3. HVAC system troubleshooting
4. Process knowledge
Behavioral Competencies
1. Team work
2. Leadership
3. Accepting challenges
Sincerely,
Dustin Wallace
Sr. Recruiter
RHO Consulting Solutions
908-818-8764
dustin.wallace@rho-inc.com
www.rho-inc.com
WBE Nationally Certified - EST. 1981
Estimated Salary: $20 to $28 per hour based on qualifications.
RHO Consulting solutions
job
Description:
Minimum Educational Qualifications required for the job: Bachelor's Degree in Mech./Electrical Engineering
Minimum years of Experience required for the job: Typically requires a minimum of 10
years in Pharmaceutical, Oral Solid Dosage
Reports to: Vice President / General
manager
Supervises: Maintenance Supervisors #4
Accountabilities:
1. Support production volume 3.5B tablets/capsules.
2. Maintaining manufacturing and packaging machines - Maintain manufacturing and packaging machines to perform at optimum performance level to meet production targets.
3. Provide engineering support for evaluation of new machines.
4. Utilities - Maintain HVAC Systems, USP Water, Boilers, Compressed Air, Hot Water and Electricity available in quality and quantity to meet production targets.
5. Facility - Maintain Three facilities total 300,000 sq. ft. approx. at all times to acceptable level of FDA, OSHA, Fire Systems and environmental agency compliance.
6. Maintenance Budget - Prepare annual maintenance budget forecast and monitoring.
7. Capital Projects - From $10,000 up to $.5M. Prepare capital project proposals in line with the requirements, implementation and timely completion.
8. Compliance - Maintain Engineering Documentation up to date to the requirements of FDA, EU, OSHA, Environmental, Local Township, Insurance Carrier, and NFPA.
9. New Product Launches - Coordinate and provide appropriate support to Product Development and Production to launch products in time.
10. Plan activities by the Engineering and Maintenance Department, supervise the execution of planned maintenance, and manage contracted
services
including; housekeeping, manufacturing, calibrations, HEPA filter testing, grounds keeping, pest control, and spare parts.
Level of Responsibility:
1. Break down and corrective Maintenance of Manufacturing, Packaging, Utility and Facility systems, providing maximum availability of machines to the users within limitations.
2. Evaluate new machine requirements, identify appropriate manufacture.
3. Provide necessary engineering support to alleviate operation technical issues, so that Product Development completes development and new product launches.
4. Project coordination: Develop scope for new project, review scope with users, hiring of designing engineers, review of drawings, obtaining bids from contractors, evaluating bids for completeness, executing construction, support validation activities as applicable, handover to the user.
5. Large Project - Recommendations, temporary facility connections, assisting temporary shut downs, providing operational sequences for utilities, security, alarms and fire suppression systems.
6. Evaluate, address and complete incomplete and any deficiencies of large projects.
7. Cost saving - Recommend management for cost saving proposals. Work with user to help complete activities needed for any cost saving projects.
8. Training - Ensure maintenance mechanics are trained. Organize training for new systems, equipment with respective contractor / supplier. Provide refresher training to mechanics. Assess individual skills and prepare development plan to address deficiencies.
9. Coordinate safety related issues, implements safety recommendations.
10. Audit - Coordinates for internal and external audits, prepares site for the audits, and provides requested information within acceptable time. Implements post audit recommendations.
Scope: OHM Laboratories Inc.US facilities (Livingston Ave, Terminal Rd, Vandyke Ave)
Dimension: Facility - 300,000 sq.ft.,Granulation suites - #14, Compression machines - # 15, Film Coating- #9, Encapsulation - #7, Bottling lines - #5, Cartoners - #4, Blister Pack, Air Handling Units - 55, Chillers - 8, Boilers - 11,Air Compressor - 6, Pumps - 48.
Financial
o Annual engineering personnel budget:$1.4 M
o Expenses:$3.5 M
o Projects - $.5 M
Staff
o Direct Reports: 4
o Indirect Reports: 35
Delegation of Responsibility: The job responsibilities can be delegated to Project Manager / Maintenance Supervisors
Job Profile:
The Engineering Director is directly responsible for providing direction and leadership to the engineering managers which execute all Engineering related activities carried out on-site (automation, capital projects, utilities, equipment, etc.). Directly responsible for the management of internal company assets, departmental personnel, external professional Engineering and other firms as part of the execution of equipment, facility or utility modification / upgrade, or expansion projects. This direct management responsibility includes all support activities and functions necessary to ensure successful completion of engineering project objectives.
Provides approval for Engineering and facility designs from the site; Manufacturing (who approve designs from a manufacturing operations perspective): Quality (who approve designs from a regulatory compliance standpoint); Ensure all facilities, utilities and/or equipment are handed over effectively to site User Departments and Maintenance personnel. Accountable for Engineering and Site Capital Project budgets; Build long-term Engineering plans; perform any other activities as required. Ensures all work carried out and equipment installed has been done safely, effectively and in compliance with the appropriate industry standards.
Ensures all company and site Engineering policies and procedures are adhered to.
Manages engineering leadership to ensure all work undertaken is reflected accurately in up-to-date Engineering, Project and Maintenance information files.
Partners with site senior management to identify the current and future engineering needs of the site. Develops and implements the strategy required and reports project status to senior management as necessary.
Provides guidance to the engineering team regarding direction and information provided to external professional Engineering firm(s), which have been engaged in the design and/or construction elements of site projects.
Manages site activities necessary for successful execution of project(s) and ensure these are completed as necessary to tie in with the overall project execution.
Manages and resolves technical issues or changes arising throughout Engineering project life cycle(s) while ensuring the overall project objectives of scope, cost and schedule are adhered to.
Ensures that all activities are in compliance with cGMP, OSHA and EPA regulatory requirements.
This
position
has direct responsibilities for Engineering support group for Calibrations, PM and Purchasing of spare parts.
Assessment and Planning of Work
Maintenance -90%
Project -75%
Technical- 45%
Areas where decision is made independently:
Maintenance - 85%
Projects - 75%
Areas where decision is made in consultation with others:
Maintenance and scheduling 15%
Projects - 15%
Areas where decision are delegated to a higher level:
Projects - 10%
Problems/ Key Features
1. Deliver critical requirements immediately
2. Arrange external help immediately
3. Advise alternate means to come out of crisis
4. Crisis management
Interface:
Internal - Production, QC, Warehouse, Purchasing and Planning
External - Contractors, suppliers and regulatory bodies.
Competencies Required:
Technical Competencies
1. Machine repairs
2. Alternate sourcing
3. HVAC system troubleshooting
4. Process knowledge
Behavioral Competencies
1. Team work
2. Leadership
3. Accepting challenges
Sincerely,
Dustin Wallace
Sr. Recruiter
RHO Consulting Solutions
908-818-8764
dustin.wallace@rho-inc.com
www.rho-inc.com
WBE Nationally Certified - EST. 1981
Estimated Salary: $20 to $28 per hour based on qualifications.
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