Sr. Process Engineer
Location: Greenville, North Carolina
Schedule: Full-Time
Work Model: On-site
Type of Contract: Permanent
Pay Rate: $75000 - $90000 / per year

About the Role:
The Sr. Process Engineer will lead and optimize critical manufacturing processes within a highly regulated cleanroom environment. The role requires expertise in steam sterilization, critical utility systems, and validation protocols, as well as a commitment to ensuring compliance with industry standards. This is an opportunity to drive continuous process improvements, collaborate across teams, and ensure the highest levels of quality and regulatory standards.

Key Responsibilities:

Sterilization & Critical Process Oversight: Design, operate, and optimize steam sterilization processes and related equipment.
System Design & Implementation: Provide technical expertise in the selection, installation, and troubleshooting of critical utility systems (e.g., PSGs, boilers).
Validation & Compliance: Execute User Requirements Specifications (URS), Validation Master Plans (VMPs), and IQ/OQ/PQ protocols in alignment with ISO 13485, cGMP, and FDA regulations.
Project Management: Lead cross-functional teams to ensure successful project execution, managing timelines, budgets, and resources.
Continuous Improvement: Implement Lean Six Sigma or equivalent methodologies to drive process optimization.
Technical Support & Training: Provide subject matter expertise and deliver training on best practices for critical systems.
Health, Safety & Environment (HSE): Maintain safety standards and promote a culture of compliance and safety.
Qualifications & Skills:Education & Experience:

Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
5-7 years of experience in pharmaceutical, medical device, or biotech sectors.
Proven expertise in managing cleanroom operations with knowledge of ISO 14644 standards.
Hands-on experience with critical utility systems (e.g., PSGs, boilers) and steam sterilization methods.
Technical Skills:

Strong knowledge of ISO 13485, cGMP, and FDA regulations.
Proficiency in Lean Six Sigma or similar methodologies.
Ability to execute URS, VMPs, and IQ/OQ/PQ protocols.
Familiarity with automation and control systems is a plus.
Excellent troubleshooting and root cause analysis capabilities.
Soft Skills:

Strong communication (written and verbal) and collaboration skills across cross-functional teams.
Leadership abilities with experience in guiding project teams.
Highly detail-oriented, ensuring high standards in documentation and execution.
Proactive problem-solving skills, especially in high-pressure environments.
Initiative to identify areas for improvement and drive innovative solutions.
Perks & Benefits:

Competitive compensation package.
Opportunity for professional growth in a dynamic and innovative environment.
Flexible work environment (relocation required by Q4 2025-Q1 2026).
Travel opportunities (up to 25% domestic and international).
Health, Safety & Environment (HSE) focused workplace.
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