Responsibilities:
- Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures. - Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
- Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
- Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
- Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and
recommendations for process and/or system modifications. - Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
- Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations
- Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
- Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
- Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.
Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field).
Experience supporting HVAC, utilities, and facility systems within a regulated pharmaceutical or biotechnology environment.
Knowledge of GMP requirements and applicable regulatory standards.
Experience in troubleshooting, optimizing, and modifying facility systems.
Knowledge of preventive maintenance strategies, facility modifications, and capital projects.
Ability to collaborate with cross-functional teams, including Facilities, Maintenance, Manufacturing, Quality, Validation, and EHS.
Ability to coordinate with external engineering firms and service providers.
- Strong analytical, problem-solving, and communication skills.
- Nonstandar shift 12hr.
Skills Required
- Bachelor's degree in Engineering, such as Mechanical, Electrical, Chemical, Industrial, or a related field
- Experience supporting HVAC, utilities, and facility systems in a regulated pharmaceutical or biotechnology environment
- Knowledge of GMP requirements and applicable regulatory standards
- Experience troubleshooting, optimizing, and modifying facility systems
- Knowledge of preventive maintenance strategies, facility modifications, and capital projects
- Ability to collaborate with Facilities, Maintenance, Manufacturing, Quality, Validation, and EHS teams
- Ability to coordinate with external engineering firms and service providers
- Strong analytical, problem-solving, and communication skills
- Availability for nonstandard 12-hour shifts, extended hours, and weekends
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
