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EMMA International · 11 hours ago

Process Engineer

Indianapolis, IN

Full-time

Onsite

New Grad, Entry Level

EMMA International is dedicated to delivering quality and compliance solutions to the pharmaceutical, biotech, and medical device industries. They are seeking a highly motivated Pharmaceutical Process Engineer to optimize and troubleshoot manufacturing processes in pharmaceutical environments.

BiotechnologyManagement Consulting

H1B Sponsor Likely

Hiring Manager

Kira Jabri

Responsibilities

Process Optimization: Collaborate with EMMA International consultants and clients to design, develop, and optimize manufacturing processes, ensuring efficiency, reliability, and compliance with regulatory requirements

Documentation Support: Assist in preparing and maintaining accurate documentation, including batch records, process instructions, and standard operating procedures (SOPs), tailored to client needs

Equipment and Process Monitoring: Support the performance monitoring of production equipment and troubleshooting efforts to minimize downtime and improve efficiency

Regulatory Compliance: Work with clients to ensure adherence to Good Manufacturing Practices (GMP), FDA regulations, and other applicable industry standards

Data Collection and Analysis: Collect, analyze, and interpret process data to identify trends and recommend process improvements for consistency and quality

Collaboration: Work closely with cross-functional client teams, including quality assurance, research and development, and production staff, to support manufacturing activities

Validation Activities: Assist in process validation, equipment qualification, and other compliance activities in line with regulatory expectations

Safety and Quality Standards: Ensure all processes and procedures comply with environmental, safety, and workplace standards while supporting a culture of continuous improvement

Qualification

Pharmaceutical manufacturing processesGMP knowledgeAnalytical skillsProcess optimizationStatistical analysis toolsCommunication skillsTeamwork

Required

Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field

Strong analytical and problem-solving skills with a focus on continuous improvement

Basic understanding of pharmaceutical manufacturing processes (e.g., granulation, drying, compression, coating, etc.)

Knowledge of GMP, FDA, and ISO standards is a plus

Excellent verbal and written communication skills

Ability to work effectively in dynamic client environments, both independently and as part of a team

Proficiency in Microsoft Office Suite and basic statistical analysis tools

Benefits

Comprehensive training and professional development opportunities to accelerate your career.

A culture of collaboration, innovation, and excellence.

Opportunities for career growth and mentorship from industry leaders.

Company

EMMA International

EMMA International is a leading global consulting firm for the medical device, pharmaceutical, biotechnology, combination products, and diagnostics industries.

Founded in 2013

Michigan, North Dakota, USA

51-200 employees

https://emmainternational.com/

H1B Sponsorship

EMMA International has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2020 (1)