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This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70,000.00/yr - $90,000.00/yr

Direct message the job poster from Harba Solutions Inc.

Consultant - Engineering Specialist | Harba Solutions Indianapolis

Responsibilities

• Investigate and document deviating conditions or nonconforming events across multiple technical departments, in coordination with Subject Matter Experts (SMEs).
• Proactively gather facts, analyze data, and interpret findings to support thorough investigations and accurate root cause identification.
• Utilize various analytical tools such as Ishikawa (Fishbone) diagrams and 5 Whys to identify root causes.
• Develop innovative corrective and preventive actions (CAPAs), leveraging automation and engineering controls to mitigate errors in processes and equipment.
• Translate complex technical processes into clear, concise, and easy-to-understand documentation.
• Collaborate with internal and external stakeholders to present investigation findings logically and comprehensively.
• Review historical deviations, adverse events, and non-conformances to detect and prevent recurring issues or trends.

Qualifications

• Bachelor’s degree in a scientific, engineering, or technical field.
• Minimum of 3 years of experience in technical writing within a GMP-regulated environment, preferably in pharmaceutical, biopharmaceutical, or biotechnology industries.
• Proven ability to produce clear, concise, and accurate technical documentation.
• Strong knowledge of GMP manufacturing processes and applicable regulatory standards.
• Experience with electronic document management systems (EDMS) and other documentation tools.
• Advanced proficiency in Microsoft Word and Excel, with strong overall computer skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Writing/Editing, Manufacturing, and Quality Assurance

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Food and Beverage Manufacturing

Referrals increase your chances of interviewing at Harba Solutions Inc. by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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