Sr. Specialist Tech Engineering

SUMMARY

The Sr Specialist Tech Engineering role will provide and/or direct process optimization strategies and/or troubleshooting of operational issues in the site utilities operation, HVAC systems, Cooling Towers, and chilled water distribution. Applies advanced and diverse maintenance principles to the design and implementation of major system modifications, experiments, process and/or capital projects. This role is crucial for our company's success, and it will be a key individual contributor leader in the Facilities and Engineering organization, reporting to the Central Utilities Plan Team.

Position Overview: The Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of F&E and manufacturing facilities. This role involves providing crucial support in Quality Systems, including deviations, Corrective and Preventive Actions (CAPAs), Change Controls, documentation changes, pest control program management support, and OEFM electronic forms.

PREFERRED QUALIFICATIONS

• Strong knowledge and demonstrated experience with Quality Systems, particularly deviations, CAPA management, Change Controls, and controlled documentation.
• Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred.
• Some understanding of pest control programs within a regulated manufacturing environment.
• Knowledge of regulatory requirements, including FDA and other relevant authorities.
• Excellent organizational, communication, and problem-solving skills.
• Detail-oriented with a focus on quality, compliance, and timely execution.

Key Responsibilities:

1. Quality Systems:

• Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
• Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
• Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.

2. Documentation Changes:

• Facilitate and manage documentation changes related to facilities and engineering processes.
• Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
• Collaborate with relevant stakeholders to implement documentation changes efficiently.

3. OEFM Electronic Forms:

• Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms.
• Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines.
• Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues.

4. Pest Control Program:

• Support the transformation of the Pest Control program into a state of the art program.
• Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
• Support the documentation and records related to the pest control program.

5. Change Controls:

• Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
• Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
• Maintain Change Control records and provide support during regulatory inspections.

SHIFT

First Shift (6am-2pm), 8 hours per day, 40 hours per week, Must be available to work non standard shifts if needed.

EDUCATION/LICENSES

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

Competencies/Skills

• Working knowledge of pharmaceutical/biotech processes.
• Specialized industrial chilled water, cooling towers and HVAC systems expertise.
• Familiarity with validation and documentation processes in a highly regulated environment.
• Deviations and CAPA management capabilities
• Problem solving skills with the ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting.
• Flexibility to work extended shift and/or weekends as per business needs.
• Skills in the following areas: Negotiation, Persuasion, Collaboration, Project cost development, Conflict Resolution, Leadership, Team building & Schedule and Resources loading development.

FUNCTIONS

• Evaluate and optimize Preventive & Predictive maintenance Job Plans at the HVAC/Process Chilled Water & Cooling Towers systems.
• Support Maintenance technical teams on the corrective and troubleshooting activities on the exposed systems above.
• Align within Corporate and site engineering policies and procedures that impact multiple organizational units.
• Supervise, coordinate and review work contractors/suppliers on an ongoing basis as well as on a project basis.
• Serves as a peer recognized as technical expert in the area of chilled water, cooling towers and HVAC, with overall responsibility for determining methodologies in that area.
• Operate under a culture of problem solving and continuous improvement.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop technical solutions to complex problems using ingenuity, innovation and creativity.

Job Types: Full-time, Contract

Pay: $75.00 - $78.00 per hour

Expected hours: 40.0 per week

Experience:

• Leadership: 3 years (Preferred)
• Facilities maintenance: 4 years (Preferred)
• Deviations and CAPA: 3 years (Preferred)
• Change Control Documentation: 3 years (Preferred)

Work Location: In person