Process Engineer (Sterilization)

1. JOB SUMMARY

The Engineer is responsible for providing day-to-day technical support to manufacturing operations, ensuring process stability, compliance, and continuous improvement.

Work requires originality and judgment in independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.

Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties.

Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

2.ESSENTIAL DUTIES

• Receive the assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Implements and understands FDA or regulatory requirements as necessary.
• Apply technology principles to multiple tasks.
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Advises team members pro-actively on technical ideas and promotes skill development of team work.
• Perform root cause investigations for NC/CAPA, ensuring systematic, data-driven solutions.
• Interacts with peers across projects to secure resources and commitments.
• Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Presents effectively complex technical information, analysis, and responds to questions from technical staff members and management.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

3.MINIMUM QUALIFICATION REQUIREMENTS

EDUCATION

• Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

EXPERIENCE

• Minimum 3 years experience.
• Two years of GMP manufacturing experience required.

SKILLS

• Requires demonstrated skills in technical innovation, mechanical and or chemical engineering, fluids engineering, and cellular biology.
• Interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member,
• Team behavior, and support for subordinates, junior engineers, technicians, and management.
• Technical problem-solving skills.
• Mechanical and electronic ability aptitude to assist with equipment trouble-shooting.
• Understanding of and adherence to GMP practices and FDA regulations.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

ADDITIONAL SKILL FOR STERILIZATION (OPTION)

• ISO11135 and / or ISO17665 experience preferable

-Or-

• An equivalent competency level acquired through a variation of these qualifications may be considered.