Looking for a new role as a EMMA International in Indianapolis, IN? This Contract position is perfect for professionals in the Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing sector. Gain hands-on experience in the Manufacturing, Quality Assurance, and Supply Chain department, where you’ll be at the forefront of exciting projects and innovation.
Why This Job Is Great for You:
- Employee Rating: Rated 3.4/5 by employees — get a sense of the company culture!
- Job Level: This role is ideal for professionals at the Mid-Senior level Level Job.
- Posted: Posted 14 hours ago, this role is still accepting applications. Act fast and apply today!
This opportunity offers valuable experience in the Manufacturing, Quality Assurance, and Supply Chain department and will help you advance your career in the dynamic world of Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing.
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“EMMA International” Company Job Details
- Company Name: EMMA International
- Work Type: Contract
- Rating: 3.4 / 5
- Location: Indianapolis, IN
- Industry: Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing
- Department: Manufacturing, Quality Assurance, and Supply Chain
- Experience Level: Mid-Senior level
- Job Creation Duration: 14 hours ago
Job Details of Pharmaceutical Consultant
Job Summary
EMMA International, a leading consulting firm in the medical device, pharmaceutical, biotechnology, combination products, and diagnostics industries, is seeking a highly motivated and experienced Consultant to join our team. This role will focus on providing technical expertise to clients in the pharmaceutical manufacturing industry, specifically in validation, investigations, and compliance with regulatory requirements.
Essential Duties
- Provide technical expertise and support to clients in validation activities, including equipment, process, cleaning, computer system, and facility validation.
- Author and execute validation protocols (IQ/OQ/PQ), ensuring documentation meets regulatory and client requirements.
- Conduct thorough investigations for deviations related to validation failures and recommend corrective and preventive actions (CAPAs).
- Develop, review, and enhance validation documentation, including validation master plans (VMPs), protocols, reports, and standard operating procedures (SOPs).
- Ensure compliance with FDA regulations, cGMP, ICH guidelines, and other global regulatory requirements related to validation.
- Evaluate and improve validation strategies and lifecycle management practices across equipment and processes.
- Implement Lean Six Sigma methodologies to enhance validation processes and reduce inefficiencies.
- Lead validation projects and coordinate with cross-functional teams including QA, manufacturing, engineering, and IT.
- Effectively communicate technical findings and recommendations, presenting validation data and conclusions clearly to clients and regulatory inspectors.
- Collaborate with client teams to drive continuous improvement initiatives in validation and qualification activities.
Qualifications
- 3+ years of experience in validation within the pharmaceutical, biotechnology, or life sciences industry.
- Strong understanding of cGMP, FDA regulations, ICH guidelines, and validation best practices.
- Experience authoring and executing validation protocols and reports.
- Lean Six Sigma certification preferred, with a proven track record of driving process improvements in validation.
- Strong technical writing and communication skills, including experience preparing VMPs, risk assessments, and validation documentation.
- Expertise in validation lifecycle management and risk-based validation approaches.
- Ability to work independently and manage multiple validation projects simultaneously.
- Must have advanced experience with deviation investigations and issue resolution related to validation activities.
- Bio/Pharma industry experience preferred.
Education & Additional Requirements
- BA/BS in Engineering, Life Sciences, or a related scientific discipline.
- Willingness to work on-site at client facilities as needed.
- Experience in manufacturing environments, including validation of equipment, processes, and systems.
- Availability to work various shifts as required to support validation activities and compliance deadlines.
If you are passionate about validation and looking for an opportunity to work with a dynamic team of industry experts, apply today!
To apply, please send a cover letter and resume to careers@emmainternational.com.