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Mechanical Engineer Manager

Location:
Howell Township, NJ, 07731
Salary:
95,000 per/year
Posted:
May 15, 2020

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Resume:

adc8n7@r.postjobfree.com H: 732-***-**** C: 202-***-**** 32 Newtons Corner Rd, Howell, NJ 07731

SUMMARY

An enthusiastic, creative professional with a proven ability to manage various functions within Industrial Facilities / pharmaceutical and Cosmetologist packaging. Help an organization define and measure progress toward organizational goals. Responsible for planning, directing, implementing and developing lines of accountability for organizational safety programs to ensure a safe, healthy, and accident-free work environment (5S, KPI’s). Working closely with multiple leaders, designs, develops and implements programs promoting a culture of safety. Establishes manufacturing operations operational strategies by evaluating manufacturing operations trends; Proficient in learning and working within ERP/MRP Systems establishing critical measurements. Implement and maintain effective operations and maintenance practices that provide high levels of equipment/facilities run ability and efficiency. Coordinate and conduct training on the new CIP cleaning or cleaning-out-of-place, to achieve a sanitary clean, with the basic cleaning principles of (TACT) Time, Action, Chemical, and Temperature. Responsible for directing, guiding, and optimizing CMMS - the ability to create a PM program, Purchase Order program and Parts Management program and supporting the overall operations (LEAN, Six Sigma Projects, TPM Projects, ISO 9001, ISO 13485:2003), of assigned area/shift improvement. Coordinate and conduct training on Serialization for operator personnel, supervisors and support Go-live activities. Develop, maintain, and enforce company operating procedures and standards (SOPs, GMPs, FDA, OSHA). Coordinate forecasted production schedule with the planning and Maintenance Department by reviewing production line availability and equipment utilization.

Education

University of Valle, Cali, Colombia 1990 – 1994

Major: Bachelor's Degree in Mechanical Engineer.

Sena Technical School, Cali, Colombia 1991-1993

Major: Architectural Drawing Technician

Accomplishments

Project Management (PMP) Started on January 2020

Black Belt High Pressure Boiler BO HP CHG, May

Electrical Safety, U.S. Department of Labor.

Arc Flash NFPA 70E – Electrical Safety

21CFR Food and Drugs Part 1300 to End. Security; ICAO/IATA and U.S. DOT. Security; ICAO/IATA and U.S. DOT,

29 CFR 1910 OSHA General Industry Regulations, School of Public Health UMDNJ,

University of South Florida & U.S. Department of Labor OSHA 29 CFR 1910 General Industry

Micro-Main XM Certified, Micro-Main Corporation,

Basic Hazardous Materials Transportation Training Program International Air Transport Association Requirements,

Section 1.5 and the U.S. DOT’s requirements 49CFR 172.704 on General Awareness, Function Specific, Safety and

Security; ICAO/IATA and U.S. DOT,

Microsoft Word, Word perfect, Power-point, Excel, Visio 2017, Microsoft Access and Auto CAD.

Professional Experience:

Process & Packaging / Manager (Contract)

Renaissance Pharmaceutical Comp. February 2019 to October 2019

Purpose:

Provide leadership and direction for production teams ensuring excellence in execution. Appropriately manage and allocate production personnel and resources to meet the production schedule. Provide leadership to production teams from development through commercialization for existing products and the introduction of new products while operating in a cGMP manufacturing environment. Champion an environment of safety, innovation, lean continuous improvement and adherence to GMPs.

Key Results Areas:

1.Implement and drive strategies within production area to support company vision and achieve departmental objectives. As the leader of the production team, oversee the day-to-day operations to ensure the pharmaceutical products produced that meet both internal and pharmaceutical quality standards. This includes but is not limited to:

1.Developing and executing production plans to meet the production schedule.

2.Managing production staffing levels and coordinate, with production planner, the allocation of personnel and resources.

3.responsible for observing and supervising the daily operations of the sterile filling, compounding, CIP System, and sanitization personnel aseptic plus gowning and media qualification for interaction during production activities.

4.Supervision of shift supervisors and production planner. Supervision of other production personnel as necessary.

5.Collaboration with Engineering, R&D, and Project Management.

My primary duties: Actively participates in Senior Management Team in reviewing progress, developing strategies, establishing polices, building a robust infrastructure, maintaining a healthy business, and directing the course of the company, and contributor to continuous Improvement and lead all facility maintenance activities of the organization.

Calibration & Maintenance Facilities and Packaging Equipment: Tube Fillers single and double heads, Piston Liquid Filler EC, SC or viscosity material (1000ml-5000ml) Label’s, Case sealers, Caper System, Cartoner’s, Caper Neck Bander equipment, Resina Caper, Pump Placer Equipment, Conveyor Belts, Blister equipment, Laser System, Video Jet System, and Serialization system Installation and Qualifications (FAT-SAT-IQ-OQ-and PQ) Validations. Millipore Water System, Atlas Copco FD Air Dryer system, HVAC and ventilation system, Blender, PWS 8-5 Precision Water System’s Distiller, Thermo Forma 3682 Scientific Lab Refrigerator/Freezer.

Coordinating, and monitoring products through the complete production cycle while supporting and following manufacturing quality controls and procedures in accordance to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.

Manage four (4) Supervisors, eight (8) packaging mechanics, four (4) facilities Maintenance Mechanics, and one hundred and five (105) Packaging personnel and machine Operators, and nine (9) Line Leaders.

Resolve personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.

Maintain working relationship with the union by following the terms of the collective bargaining agreement.

Ensure efficient operation of equipment by calling for repairs, facility maintenance requests, evaluating new equipment and processes.

Contribute to the writing and review of documentation such as SOPs and PRs.

Participates in plant staff, shift and safety meetings, and conducts regular departmental meetings and departmental training based on needs assessment.

Oversee ordering, receiving, storing, cleaning, sterilizing, issuing and usage for equipment and supplies used in Manufacturing.

Maintain and update all environmental procedures according with EPA of NJ

Investigates and diagnoses causes of breakdowns and develop programs and solutions to reduce/eliminate future occurrences.

Maintains direct contact with the Engineering department on the latest improvements to plant machinery and systems to more effectively increase manufacturing performance and reduce operating costs.

Direct and oversee all daily maintenance activities including CMMS, delegation of tasks, tracking performance and directing the processes of any necessary repairs.

Determines and controls maintenance budget to ensure efficient use of funds and reduce/eliminate repetitive purchases by identifying and eliminating root causes.

Coordinate with engineers when inspectors are required to evaluate and inspect the facilities.

Technical: Knowledge of, or ability to obtain knowledge of, equipment and production processes.

Execution: Action and results oriented with a can-do attitude. Implements systems, processes, procedures, specifications and corrective

actions that support and deliver results relative to strategic vision.

Influencer: Successfully influences peers, leadership, customers and employees to resolve issues and create alignment toward goals and objectives.

Serialization Support:

Conduct system user training for operators and supervisors and support Go-live activities.

Assist existing teams in software qualification and software validation activities and further help Serialization support team to manage serialized lines.

Participate in internal and external audits related to Serialization.

Perform all the foregoing work in IT, QA, manufacturing, distribution, Regulatory, and/or product labeling in the pharmaceutical.

Facilities Maintenance & Packaging - Manager

Akorn Pharmaceutical Inc. April 2017 to February 2019

Summary of Duties and Responsibilities:

Oversee, manage and direct all maintenance procedures and operations

Perform evaluations of employees to ensure quality of work

Oversee all maintenance activities within the Maintenance Department.

Actively participates in Senior Management Team in reviewing progress, developing strategies, establishing polices, building a robust infrastructure, maintaining a healthy business, and directing the course of the company.

Responsible for the overall plant maintenance and coordination of activities with other departments in a manner which results in the production of quality product at a cost and schedule consistent with company policies, customer service and plant objectives.

Develop and implement preventive maintenance programs and continuous improvement initiatives for cost-effectiveness.

Takes an active leadership role in development and implementation of continuous process improvement tools in assigned department(s).

responsible for observing and supervising the daily operations of the sterile filling, compounding and sanitization personnel aseptic plus gowning and media qualification for interaction during production activities.

Responsible for reviewing all sterile production documentation

Responsible for coaching and training sterile department personnel in SOP's, cGMP's, aseptic gowning and aseptic technique.

Responsible for reviewing logbooks, batch records and all production related documents.

Work with equipment operations team to schedule and prioritize all on demand equipment work orders.

CMMS – the ability to create a PM program, Purchase Order program and Parts Management program.

Assigning tasks and overseeing maintenance / Packaging mechanics staff functions, implementing changes

Interface with OEM (Original Equipment Manufacturer) to schedule routine and on demand work requests, to request spare parts and expedite services as required.

24 hours “on call” status for equipment emergency repairs (Facilities and Packaging)

Schedule, oversees, and performs Preventative Maintenance (PM) an all production and facility equipment.

Requests, schedules, and oversees the activities of various contractors working throughout the facility.

Responsibilities include interviewing, hiring, planning, assigning, and directing work, appraising performance and addressing complaints & resolving problems.

Create and maintain Standard Operation Procedures (SOPs) for preventive maintenance of all plant equipment and facility

Coordinate with outside contractor when providing services throughout the facilities, such as, the HVAC system, environmental temperature control system, electrical, hydraulic dock system, roof system and refrigeration system.

Serialization Support:

Assist existing teams in software qualification and software validation activities and further help Serialization support team to manage serialized lines, implementing changes

Conduct system user training for operators and supervisors and support Go-live activities.

Work with IT and Packaging line serialization systems to support global Serialization regulatory requirements.

Facilities Manager Engineer at Research Center

Dr. Reddy’s Laboratories December 2014 – March 2017

Summary of Duties and Responsibilities:

Manage and coordinate facilities related capital projects such as modification of offices and laboratories, as well construction of new offices and laboratories with responsibility for results in terms of costs, methods, and employees, including the coordination and supervision of outside contractors, vendors and consultants.

Responsible to conduct maintenance in accordance with FDA, DEA guidelines, GMP, SOPs.

Responsible for the daily execution of production activities including but not limited to providing key leadership, direction, organization, management, monitoring and cGMP compliance of the roles, activities and proceedings of Operations in order to

ensure the successful, cost effective, timely and safe processing of client projects.

Responsible for receiving, coordinating and planning work related to on-demand work orders and routinely scheduled maintenances. also coordinate work with outside vendors.

Works with other corporate departments, plants, contract manufacturing, consultants, and suppliers under supervision.

Responsible for directing, guiding and optimizing maintenance hourly labor in the execution of maintenance plans and supporting the overall operations of assigned area/shift (LEAN) quick change over, and incorporate 5S system among all departments.

Modification of present equipment resulting in cost savings 35.0%

Perform mechanical, hydraulic and pneumatic systems inspections following established SOP, JSA’s or other written or verbal instructions.

Support to the External Manufacturing Organization and assigned contract manufacturing organizations (CMO's), ensuring the transfer of robust manufacturing and packaging processes to CMO's.

Calibration & Maintenance Process, Facilities, and Lab Equipment: Master Mixer, Stability Chamber, MFB-1 EX Fluid Bed Processor, Engineering NP100 Bi-Layer Tablet Press double and triple layer system, P-K Blend Master Lab V – Blender, PWS 8-5 Precision Water System’s Distiller, Thermo Forma 3682 Scientific Lab Refrigerator/Freezer, VWR 1415M Scientific Vacuum Oven, the Dr. Schleuinger 6D Tablet Hardness Tester, Waters 2487 Dual Absorbance Detector, Donaldson Torit VS550 Vibram Shaker, Millipore Water System, Vector Hi Coater, Atlas Copco FD 35 Air Dryer, HVAC and ventilation system, Laboratory Fume Hood, Niro Pharma-matrix PMA 25 Liter Granulator, Kilian TX Tablet Press, Fette Tablet Press 1200i, Quatro U5 Comil, Reciprocating Apparatus.

Maintain and update all environmental procedures according with EPA of NJ

Maintain manufacturing activity records in the SAP & ERP system

Direct or oversees any modification to the Table Press, Fluid Bed systems, Blenders, Coders / Laboratories equipment that would improve reliability or cost effectiveness.

Coordinate with outside contractor when providing services throughout the facilities, such as, the HVAC system, environmental temperature control system, landscaping, electrical, hydraulic dock system, roof system and refrigeration system.

Performance Management: Evaluating employee performance against established standards, which includes recognizing employee strengths and development needs as well as determining appropriate compensation adjustments. Proactively addressing performance issues when required.

Communication: Effectively communicates, in verbal and written form, with individuals at all levels of the organization. Builds effective relationships at all levels of the organization and inspires trust. Effectively administers and communicates company policies and procedures.

Data Driven: Understands statistics and the proper use of data. Demonstrates the ability to identify trends, draw conclusions and takes action to achieve results.

Costing: Oversees costing activities for manufactured products.

Projects: Manages projects initiated at the Thornburg facility. Other projects and duties assigned by Director.

Risk Management: Understands and has applied risk management tools, application of current regulations including cGMP, quality processes, procedures and ISO standards – ISO 13485:2016, ISO 9001:2015 to job responsibilities. Develops and implements quality standards, procedures, specifications, and corrective actions.

Administration and Accounting

Ensures biweekly payroll activities take place for pay calculation

Communicates and enforces policies.

Maintains safe and comfortable work environment of office employees.

Accountable for administration budget and general expenses.

Administrator for the Drug Enforcement Administration (DEA)

Worked with Engineers to design and build a new DEA Vault.

Direct contact to DEA and first individual notified when Vault or Cages Alarm are activated Vault /Cages Contain

Controlled substances.

Provide confidential and personal information to the (FBI) and State Police when new employee is assigned to the Cage

Responsible for the accounting, recording and verifying that a proper procedure of packaging is maintained.

Production - Packaging Supervisor

Church & Dwight Company July 2013 – December 2014

Manufacturing:

Provides focus, guidance, and opportunities for input on employee safety, employee comfort, team cohesiveness, product safety, product quality, and customer service.

Manage eight (8) Line Leaders. Nine (9) packaging mechanics, Seventy-five (75) Packaging personnel and machine Operators.

Ensures manufacturing process meet requirements of timeliness and cost effectiveness, and criteria stipulated by Ministry of GMPs, SOPs, FDA and private label customers.

Production:

Oversees, reviews, and assists troubleshoot daily production operations, scheduling employees to meet the daily/weekly production requirements.

Determine a production schedule to meet customer orders understanding correct sizes by farm or bin/lot numbers.

Establishes and effects practices that emphasize production of safe, quality and preventative maintenance

Oversees recruitment, compensation, disciplinary actions, performance evaluation, and dismissal of employees

Production Manager - FLEXPAQ ILEOS South Plainfield NJ June 2009 – July 2013 (Bought out) Summary of Duties and Responsibilities:

Responsible for managing All Operations department

Identifying and leading the development of best practices for a maturing department

Organizing a team and work processes to support a high level of work volume

Developing detailed action plans to drive continuous improvement

Specific job duties include:

Manage large packaging department

Participate in customer meetings, lead customer requests for resolution of ongoing packaging issues.

Assist in project management activities for key customer projects.

Establishes and effects practices that emphasize production of safe, quality and preventative maintenance

Leading, managing, hiring, and training crew of production hourly workers (Temps) responsible for managing all the production related.

Ensuring production goals are met or exceeded, including yield, throughput, and quality 85.0% improvement.

Partnering effectively with maintenance and engineering to optimize equipment performance and reliability and assisting with Lean projects.

Maintain manufacturing activity records in the system CMMs.

Manage six (6) Supervisors, eighteen (18) facilities and packaging mechanics, One Hundred and fifteen (115) Packaging personnel and machine Operators, and sixteen (16) Line Leaders.

Strong management and leadership skills and ability to effectively lead and motivate a diverse group of hourly employees.

Minimize equipment downtime through effective management of production staff and working with maintenance and scheduling

Delivers customer-acceptable products by enforcing quality standards, maintaining GMP’s.

Change Management: Successfully lead people and departments through change initiatives including people, processes, and cultures.

Financial: Managing to a budget and rudimentary understanding of business financials.

Production Packaging Mechanics Supervisor & HSC - Knipper Company, Lakewood, NJ March 1998 – May 2009

Production Responsibilities

Research and design (per customers’ specifications) new Pharmaceutical packaging lines.

Plan, organize, control and direct the Production Fulfillment Department and its support groups in the production of a high-quality product at a minimal cost to the company in a safe and sanitary environment.

Accountable for supporting packaging projects to assure they meet quality and consumer expectations while maintaining project.

Moves personnel and staff to maximize proper use of manpower, skills, equipment and facilities.

Perform mechanical, hydraulic and pneumatic systems inspections for Pharmaceutical and Cosmetology Packaging Equipment’s.

Packaging Lead Mechanic - West Pharmaceutical Company, Lakewood, NJ January 1994 – April 1998

Coordinate specific actions with management team

Repair and set-up packaging equipment’s coordinate the change-over schedule for production line, and perform mechanical, hydraulic and pneumatic systems and inspections for Pharmaceutical Cosmetology Packaging Equipment’s.

VL



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