The Automation Engineer is responsible for supporting ongoing manufacturing processes, developing/designing manufacturing processes for new products, and ensuring effective communication and coordination between all participating departments. The Engineer plans and conducts small to medium sized projects requiring conventional types of plans, investigations, and equipment. Assignments include system, equipment or process design and development; equipment start-up, construction site responsibilities; preparation of specs or bid packages; regulatory and safety compliance. The Engineer's primary objective is to ensure that manufacturing processes are capable, compliant, in control, and continuously improved.
Manufacturing Process Development
- Interfaces with R&D, technical operations, manufacturing, packaging, purchasing, and quality departments to design efficient and reliable manufacturing processes.
- Generates change controls to introduce new or modify existing equipment/systems.
- Develops and executes equipment and system qualification protocols to ensure compliance and adherence to cGMP and Company standards.
- Executes engineering studies related to in-process testing (e.g. net weight verification, seal integrity verification).
- Creates and updates standard operating procedures for setup, operation and cleaning of equipment.
- Works closely with manufacturers and suppliers to ensure equipment, systems, tooling, and components meet Company needs.
- Attends FATs (Factory Acceptance Tests) to verify equipment operates in accordance with cGMP and Company standards.
- Maintains process knowledge and ownership.
- May lead or participate in cross functional initiatives.
- Provides technical support and analysis for the resolution of deviations, investigations, and process issues.
- Assists in authoring manufacturing batch records.
- Organizes equipment and system training sessions for mechanics and operators.
80%
Manufacturing Process Improvement
- Evaluates, selects, and applies standard engineering techniques, procedures, and criteria to improve quality, safety, efficiency, and waste reduction.
20%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- Bachelor of Science or Master of Science degree in Chemical, Mechanical, or Electrical Engineering or related studies required with 2-5 years' progressive technical experience.
- Previous experience in cGMP manufacturing environment.
- Pharmaceutical industry experience a plus.
- Relevant college/university Internships.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Strong knowledge of 2D and 3D design software (e.g. AutoCAD, SolidWorks).
- Knowledge of cGMP and FDA regulations.
- General understanding of Lean Manufacturing and Six Sigma principles.
Skills & Abilities
Often referred to as competencies , leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Proficient with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio).
- Must have the ability to work effectively with a computerized maintenance management system and instruct others on its operation.
- Able to establish and maintain cooperative working relationship with individuals contacted in the course of work.
- Able to understand and follow oral and written instructions.
- Able to communicate clearly and concisely, both oral and writing.
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
- Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Physical Requirements
- Occasionally be required to climb or balance.
- Occasionally be required to lift and/or move up to 50 pounds.
- Occasionally exposed to outside weather conditions and risk of electrical shock.
- May be exposed to high noise environments.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.