SUMMARY
As a successful candidate for this position you will :
- Become the center of expertise in polymer chemistry and plastics extrusion
- Develop and define manufacturing processes and the equipment used to execute these processes.
- Serve collaboratively on cross functional teams to develop manufacturing process innovations concurrently with new product development.
- Provide design-for-manufacturability input to concurrent engineering (product & process development) teams.
- Integrate your areas of expertise with those of other SMEs to enable successful manufacturing systems.
- Guide and assist capital project realization teams to integrate processes into manufacturing systems installed worldwide.
- Define critical process parameters, monitoring methods and validation methods to ensure successful implementation of processing equipment in manufacturing environments.
- Serve as subject matter expert to train others in the organization and support manufacturing capability within your competencies.
- Provide on-site support to manufacturing sites in Costa Rica, India, Vietnam, and Northern Ireland as well as travel internationally to support projects as required.
RESPONSIBILITIES :
- Perform independent evaluation, selection, and application in making adaptations and modifications to projects.
- Lead portions of major significant projects and hold total management responsibility for smaller projects.
- Contribute to the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
- Implement and understand FDA or regulatory requirements as necessary.
- Apply technology principles to multiple tasks.
- Develop working knowledge of cross-functional and related technical areas.
- Approach and complete tasks, highlighting risks to avoid delays and optimize expenditure of time and resources.
- Advise team members pro-actively on technical ideas and promote skill development of teamwork.
- Interact with peers across projects to secure resources and commitments.
- Handle frequent inter-organizational and outside supplier contacts.
- Represent the organization in providing solutions to difficult technical issues associated with specific projects.
- Follow / develop technical specification requirements and provide feedback on various technical processes and procedures.
- Present effectively complex technical information / analysis and respond to questions from technical staff members and management.
- Work cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
- Work direction responsibility may include technicians and junior engineers.
- May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
QUALIFICATIONS : Education
Education
- Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- Bachelor's of Science degree or Master of Science degree in Engineering preferred.
Experience
- Minimum 8 years' experience in related fields.
- Two years of GMP manufacturing experience required.
Skills
- Requires demonstrated skills in technical innovation, technical leadership, polymer engineering and manufacturing.
- Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, and support for subordinates, junior engineers, technicians, and management.
- Represents the organization as the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
- Strong technical problem-solving skills.
- Mechanical and electronic ability aptitude to assist with equipment troubleshooting.
- Understanding of and adherence to GMP practices and FDA regulations.
- Knowledge and ability to implement FDA or regulatory requirements as necessary.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
IND123
30+ days ago