The Senior Specialist Technical Engineering role provides and/or directs process optimization strategies and troubleshooting of operational issues related to site utilities operations, HVAC systems, cooling towers, and chilled water distribution. Applies advanced and diverse maintenance and engineering principles to design and implement major system modifications, experiments, and process/capital projects. This role is a key individual contributor within Facilities & Engineering, supporting the Central Utilities Plant team. The Senior Specialist Technical Engineering is a key contributor to maintaining the integrity and compliance of F&E and manufacturing facilities. This role provides essential support in Quality Systems, documentation changes, pest control program management, and OEFM electronic forms.
Functions
- Evaluate and optimize Preventive & Predictive Maintenance job plans for HVAC, Process Chilled Water, and Cooling Tower systems.
- Support maintenance technical teams with corrective actions and troubleshooting activities for the above systems.
- Align with corporate and site engineering policies and procedures impacting multiple organizational units.
- Serve as a peer‑recognized technical expert in chilled water, cooling towers, and HVAC systems, with responsibility for determining methodologies in these areas.
- Operate under a culture of problem solving and continuous improvement.
- Develop technical solutions to complex problems using ingenuity, innovation, and creativity.
- Supervise, coordinate, and review work performed by contractors and suppliers on an ongoing and project basis.
- Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
- Coordinate work of consultants, architects, and engineering firms in developing standard design documents.
Skills
- Working knowledge of pharmaceutical/biotech processes.
- Specialized expertise in industrial chilled water, cooling towers, and HVAC systems.
- Familiarity with validation and documentation processes in highly regulated environments.
- Deviations and CAPA management capabilities.
- Strong problem‑solving skills with ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting.
- Flexibility to work extended shifts and/or weekends as needed.
- Skills in negotiation, persuasion, collaboration, project cost development, conflict resolution, leadership, team building, and schedule/resource loading development.
Requirements
- Doctorate + 2 years of Engineering experience OR
- Master’s + 6 years of Engineering experience OR
- Bachelor’s + 8 years of directly related experience.
Preferred Qualifications (must have)
- Strong knowledge and demonstrated experience with Quality Systems: deviations, CAPA management, change controls, and controlled documentation.
- Experience supporting OEFM electronic forms or similar electronic quality/facilities management systems.
- Understanding of pest control programs within regulated manufacturing environments.
- Knowledge of regulatory requirements, including FDA and other authorities.
- Detail‑oriented with strong focus on quality, compliance, and timely execution.
- Provide primary support for deviations, CAPAs, change controls, and related quality documentation.
- Investigate and document deviations per SOPs.
- Work with Quality and stakeholders to initiate, implement, monitor, and close CAPAs.
- Ensure Quality Systems records are complete, accurate, compliant, and inspection‑ready.
- Facilitate and manage documentation changes related to facilities and engineering processes.
- Ensure documentation changes meet regulatory guidelines, internal standards, and industry best practices.
- Collaborate with stakeholders to implement documentation changes efficiently.
- Support creation, completion, review, routing, and tracking of OEFM electronic forms.
- Ensure forms are completed accurately and processed within required timelines.
- Collaborate with F&E, Quality, and cross‑functional teams to resolve form‑related issues.
- Support transformation of the pest control program into a state‑of‑the‑art system.
- Collaborate with external vendors and internal teams to resolve pest control issues.
- Support documentation and record‑keeping for the pest control program.
- Support evaluation of proposed changes to facilities, utilities, equipment, and critical utilities.
- Collaborate with stakeholders to assess impact and ensure proper documentation and implementation.
- Maintain change control records and support regulatory inspections.
Benefits
- 1- year contract with possible extension
- First shift.
Skills Required
- Doctorate degree and 2 years of engineering experience, or master's degree and 6 years of engineering experience, or bachelor's degree and 8 years of directly related experience.
- Specialized expertise in industrial chilled water, cooling towers, and HVAC systems.
- Working knowledge of pharmaceutical or biotech processes.
- Experience with validation and documentation processes in highly regulated environments.
- Experience managing deviations and CAPAs.
- Strong knowledge and demonstrated experience with quality systems, including deviations, CAPA management, change controls, and controlled documentation.
- Experience supporting OEFM electronic forms or similar electronic quality or facilities management systems.
- Understanding of pest control programs within regulated manufacturing environments.
- Knowledge of FDA and other regulatory requirements.
- Strong problem-solving, collaboration, negotiation, leadership, and project coordination skills.
- Ability to work extended shifts and weekends as needed.
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
