JJJP00009543- 17/01/2022 to 31/12/2022
For our client, a leading international pharmaceutical company, we are currently looking for a new team member as a:
- Provides process engineering and controls support. Plans and conducts activities related to the development of new processes including researching current and emerging technologies, evaluating process cost, quality, and capability alternatives, and performing process characterization and optimization using designed experiments, and problem solving and decision-making tools.
- Provides technical expertise in machine safety
DUTIES & RESPONSIBILITIES
- Under supervision of the engineering manager and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Lead equipment design and validation project and process improvements projects.
- Follow compliance and EHS policies and guidelines.
- Work with vendors to procure new equipment and ensure new equipment and processes
- conform to all pertinent guidelines.
- Responsible for performing and documenting activities for IQ, OQ and PQ.
- Responsible for creating production documentation and providing input into new product BOMs, routings, and DMR.
- Provide input into regulatory submissions i.e. PMA submission. Technical writing, data analysis, data tracking and trending.
- Support raw material and supplier qualifications.
- Provide input into annual budgets and manage project spending.
- Identify and lead opportunities to reduce cost of goods for future implementation.
- Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items.
- Support critical engineering tasks in other departments as assigned.
- Use project management tools and methodologies to deliver projects on-time, on-budget, and on-scope.
- Serve as the engineering approver for process development studies and validation
- documentation when authorized.
- Provides complex technical support for project planning, development, implementation, and modification; contributes extensively to engineering standards development balancing corporate and customer needs.
- Performs complex research of new technology for potential corporate application.
- Performs complex assignments designed to continue the development of professional work knowledge and abilities requiring advanced application of standard engineering techniques, procedures and criteria in carrying out engineering tasks.
- Exercises independent judgment on significant details of work and makes selections and
- adaptations of engineering alternatives.
- Performs assignments that have complex objectives and require the investigation of multiple variables.
- Performs work which involves complex conventional types of plans, investigations, surveys, structures, or equipment with highly complex features for which there may be no precedents.
- Assignments usually include several of the following: equipment design and development, test
- of materials, preparation of specifications, process study, research investigations, and report
- Provides complex design reviews and feedback for improvements in manufacturability.
- Develops equipment, materials, and process performance requirements, performs vendor searches and equipment evaluation to ensure adequate capability to produce quality products in required quantities at effective costs.
- Designs experiments and capability studies, develops process specifications, and designs and procures process tooling.
- Analyzes new processes and equipmement the intent of achieving continuous
- improvement of present methods.
- Communicates and monitors process and material quality targets.
- Measures performance to targets and implements remedial actions as instructed.
- Develops process documentation and training materials for new processes, materials, and equipment.
- Responsible for communicating business related issues or opportunities to next management level
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
EXPERIENCE AND EDUCATION
- University / Bachelors Degree, Engineering degree or Equivalent
- Generally requires (4-6) years related experience
REQUIRED KNOWLEDGE, SKILLS, ABILITIES
- Equipment and Process Validation / Establish Equipment requirements (CAR request, URS, FAT)
- Mechanical and automation background with 6 to 10 years in industry, preferred in medical field
- Project management
- Team management and project and resource prioritization
- Manufacturing processes improvements
- Lean and/or Six Sigma belt
- Automation and vision system optimization,
- Troubleshooting and machine design review
ADDITIONAL POSITION REQUIREMENTS
- Ability to work in a team environment
- Ability to communicate across multiple levels in the organization
- Product & Process Knowledge
- CAPA, NR, Audit (internal & External)
- Machine safety
Start Date: 17.01.2022
Duration: 1 year
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).