The Specialist, Technical Engineering provides technical engineering support for system and equipment optimization, upgrades, replacements, and modifications. This role ensures that maintenance operations are executed in compliance with corporate policies, industry regulations, and FDA standards. The Specialist will serve as a key liaison between the maintenance, engineering, and compliance teams to maintain operational excellence and regulatory readiness.
Key Responsibilities
- Ensure utility systems, process maintenance, instrumentation, calibration, electrical, and technical cleaning systems meet all applicable regulatory and FDA standards.
- Maintain consistency in maintenance team training programs, SOPs, and operational standards.
- Provide technical support to the maintenance team on issues related to engineering, regulatory compliance, calibration, quality, environmental monitoring, cleaning, validation, and electrical systems.
- Support maintenance activities and provide technical assistance during FDA and other regulatory inspections.
- Assist in developing responses to FDA and other regulatory agency observations.
- Support investigations and corrective actions for high-purity water systems and environmental monitoring alert/action notifications.
- Develop and maintain an audit program for the maintenance team; conduct routine audits of operations, documentation, and systems to ensure compliance.
- Collaborate with plant engineering to evaluate and implement process improvements, compliance upgrades, and optimization initiatives.
- Evaluate sanitization and maintenance procedures and recommend process or utility system modifications to Plant Engineering.
- Propose and implement departmental improvements and policy updates as needed.
Skills
- Strong leadership and team-building abilities
- Excellent verbal and written communication, including technical writing
- Organizational and facilitation skills
- Ability to manage and adapt to change effectively
- Comprehensive understanding of validation protocol requirements
- Technical expertise in equipment and system operations
- Analytical problem-solving and project management skills
- Proficient in scheduling and computer literacy
Requirements
Education & Experience
- Doctorate in Engineering, or
- Master’s degree with 3 years of Engineering experience, or
- Bachelor’s degree with 5 years of Engineering experience, or
- Associate’s degree with 10 years of Engineering experience, or
- High school diploma/GED with 12 years of Engineering experience.
Preferred Qualifications
- Experience with MAXIMO data entry and management
- Skilled in data sheets, job plans, and MMP package creation
- Familiarity with technical drawings and schematics
- Highly organized, detail-oriented, and able to manage multiple priorities in a regulated environment
Benefits
- Contract position
- Administrative Shift
Top Skills
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.
