Engineer
4 weeks ago
Specific responsibilities include but are not limited to:
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
- Initiate and complete routine technical tasks.
- Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
- Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
- Work with consultants, architects and engineering firms on development of standard design documents.
- Acquire and critique quotes for equipment modifications or installations.
- Generate rudimentary project cost estimates and schedules.
Preferred Qualifications:
- Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
- Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
- Knowledge of pharmaceutical/biotech processes
- Familiarity with validation processes for Packaging areas
- Familiarity with serialization process and networking
- Familiarity with documentation in a highly regulated environment
- Ability to operate specialized equipment, tools and computers as appropriate.
- Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
- Ability to apply engineering science to production.
- Able to develop solutions to routine technical problems of limited scope
- Comprehensive understanding of protocol requirements.
- Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
- Excellent communication (verbal/written) and presentation skills
- Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
- Protocol and script testing Writing
- Dealing with and handling change
- Packaging Equipment Technical knowledge
- Analytical Problem Solving
- Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
- Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Contex
Top 3 Must Have Skill Sets:
- Project Management
- Problem Solving & Root Cause Analysis
- Communication and Team Work
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
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