Neolpharma Inc.
Incumbent is responsible for the satisfactory and reliable operation of the utilities systems of the site to support all pharmaceutical cGMP production processes. Typical utilities systems consist of boilers (steam generation systems), HVAC (including chillers, cooling towers, air handling units, exhaust fans, dust collectors, reheat systems, dehumidifiers, HEPA filters, vacuum systems, breathing air systems, direct expansion units, etc), air compressors, water systems (including potable and purified water systems), chemical treatment and electrical systems (including high voltage substations of 38000V, 13200V, down to plant distribution MCC’s of 480V/277V/208V/120V and emergency generators).
Maintains an effective organization through the selection, training, development and engagement of all direct reports. Promotes open door policy, diversity, continuous improvement and a safe working environment. Enforces adherence to all company policies, procedures and regulations.
PRIMARY FUNCTIONS 1. Ensures adequate operation of all plant utilities to minimize downtimes that could impact production operation, in compliance with all regulatory requirements (cGMP and Safety/Environmental).
2. Ensures appropriate execution and documentation of all utilities maintenance activities (including preventive maintenance (PM), corrective maintenance (CM) and predictive maintenance (PdM)), and in compliance with the site maintenance program. Also, ensures appropriate execution and documentation of all daily utilities operation checks and worksheet forms, in compliance with cGMP requirements.
3. Coordinates maintenance interventions windows with production and planning departments, as needed, including shutdowns.
4. Ensures and enforces compliance with all site cGMP requirements.
5. Handles and assumes responsibility of all compliance duties (utilities related), including but not limited to investigations, CAPA’s, effectiveness checks, change requests, SOP’s, PM’s, corrective work orders, audits (internal/external (clients/regulatory agencies)), etc.
6. Serves as subject matter expert for the utilities systems.
7. Promotes and implements continuous improvement initiatives.
8. Promotes energy conservation measures and environment protection awareness. Monitors and promotes continuous evaluation and search for technical solutions to reduce energy consumption of the site.
9. Manages and ensures proper operation of the Building Management Systems (BMS) and all its components.
10. Manages / resolves / facilitates / provides technical support for any utilities mechanical and electrical system and associated instrumentation and controls. This includes environmental monitoring systems (temperature, relative humidity / differential pressure), critical utilities systems and their respective control system (including PLCs, as applicable).
11. Ensures satisfactory execution of external PM’s services of calibrations and mapping studies for Stability Rooms, Stability incubators and Microbiology/Analytical Labs incubators, refrigerators and autoclaves.
12. Represents as needed the utilities operation in the development of capital projects and assists the project engineering team in the selection of best fit solutions required for the utilities operation.
13. Manages and/or support capital project requests (CAR’s) projects, as needed.
14. Manages all administrative and human resource duties for the utilities team, including time attendance, overtime control, vacation plan, trainings, development plans, evaluations, disciplinary actions, staffing/recruitment, request quotes and issue purchase requisitions, among others.
15. Ensures proper utilization of the utilities human resources.
16. Establishes the utilities engineering goals and provides direction to personnel to align with departmental goals and/or objectives.
17. Performs other duties, as assigned.
SECONDARY FUNCTIONS 1. Supports other Engineering areas or plant works, as needed.
QUALIFICATIONS
Bachelor in Degree in Engineering (Electrical or Mechanical)
Three to five years of experience working with utilities systems within pharmaceutical environment, and at least three (3) years of supervisory experience
Strong knowledge of utilities systems
In depth understanding/knowledge of:
cGMP, EHS, Controlled Substances (DEA) and any other related regulatory requirements
Computer Literacy (Maximo, Microsoft Office, business applications)
Spanish and English proficiency.
Strong communication skills (written and verbal)
Must possess flexibility to respond to constantly changing conditions and priorities
OTHER REQUIREMENTS
24/7 resource, responsible for continuous site utilities operations
Must demonstrate a continuous sense of urgency, always aligned with business, compliance, and safety (EHS – personnel safety and environment care)
Strong collaboration skills oriented to service and client satisfaction; always looking to improve systems reliability and minimize equipment downtimes to support business success
Ability to manage multiple priorities
Negotiation skills
Problem solving skills
Willing to work other shifts, per company needs.
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Maintains an effective organization through the selection, training, development and engagement of all direct reports. Promotes open door policy, diversity, continuous improvement and a safe working environment. Enforces adherence to all company policies, procedures and regulations.
PRIMARY FUNCTIONS 1. Ensures adequate operation of all plant utilities to minimize downtimes that could impact production operation, in compliance with all regulatory requirements (cGMP and Safety/Environmental).
2. Ensures appropriate execution and documentation of all utilities maintenance activities (including preventive maintenance (PM), corrective maintenance (CM) and predictive maintenance (PdM)), and in compliance with the site maintenance program. Also, ensures appropriate execution and documentation of all daily utilities operation checks and worksheet forms, in compliance with cGMP requirements.
3. Coordinates maintenance interventions windows with production and planning departments, as needed, including shutdowns.
4. Ensures and enforces compliance with all site cGMP requirements.
5. Handles and assumes responsibility of all compliance duties (utilities related), including but not limited to investigations, CAPA’s, effectiveness checks, change requests, SOP’s, PM’s, corrective work orders, audits (internal/external (clients/regulatory agencies)), etc.
6. Serves as subject matter expert for the utilities systems.
7. Promotes and implements continuous improvement initiatives.
8. Promotes energy conservation measures and environment protection awareness. Monitors and promotes continuous evaluation and search for technical solutions to reduce energy consumption of the site.
9. Manages and ensures proper operation of the Building Management Systems (BMS) and all its components.
10. Manages / resolves / facilitates / provides technical support for any utilities mechanical and electrical system and associated instrumentation and controls. This includes environmental monitoring systems (temperature, relative humidity / differential pressure), critical utilities systems and their respective control system (including PLCs, as applicable).
11. Ensures satisfactory execution of external PM’s services of calibrations and mapping studies for Stability Rooms, Stability incubators and Microbiology/Analytical Labs incubators, refrigerators and autoclaves.
12. Represents as needed the utilities operation in the development of capital projects and assists the project engineering team in the selection of best fit solutions required for the utilities operation.
13. Manages and/or support capital project requests (CAR’s) projects, as needed.
14. Manages all administrative and human resource duties for the utilities team, including time attendance, overtime control, vacation plan, trainings, development plans, evaluations, disciplinary actions, staffing/recruitment, request quotes and issue purchase requisitions, among others.
15. Ensures proper utilization of the utilities human resources.
16. Establishes the utilities engineering goals and provides direction to personnel to align with departmental goals and/or objectives.
17. Performs other duties, as assigned.
SECONDARY FUNCTIONS 1. Supports other Engineering areas or plant works, as needed.
QUALIFICATIONS
Bachelor in Degree in Engineering (Electrical or Mechanical)
Three to five years of experience working with utilities systems within pharmaceutical environment, and at least three (3) years of supervisory experience
Strong knowledge of utilities systems
In depth understanding/knowledge of:
cGMP, EHS, Controlled Substances (DEA) and any other related regulatory requirements
Computer Literacy (Maximo, Microsoft Office, business applications)
Spanish and English proficiency.
Strong communication skills (written and verbal)
Must possess flexibility to respond to constantly changing conditions and priorities
OTHER REQUIREMENTS
24/7 resource, responsible for continuous site utilities operations
Must demonstrate a continuous sense of urgency, always aligned with business, compliance, and safety (EHS – personnel safety and environment care)
Strong collaboration skills oriented to service and client satisfaction; always looking to improve systems reliability and minimize equipment downtimes to support business success
Ability to manage multiple priorities
Negotiation skills
Problem solving skills
Willing to work other shifts, per company needs.
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