Senior Process Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing sector is seeking a Process Engineer to oversee aseptic filling operations. The role involves managing capital budgets, optimizing process performance, and leading investigations to ensure product quality. Candidates should have a strong background in aseptic processes, technical documentation, and significant experience. This position offers a competitive compensation package aligned with industry standards for mid-senior level roles.

Benefits

Medical insurance

Vision insurance

401(k)

Disability insurance

Qualifications

• 7+ years experience with aseptic filling processes and equipment.
• Knowledge of validation lifecycle including IQ/OQ/PQ.
• Ability to lead investigations using DMAIC.

Responsibilities

• Oversee specification, procurement, and installation of aseptic filling equipment.
• Lead structured investigations to determine root causes of deviations.
• Draft and review technical documentation such as validation protocols.

Skills

Monitoring and analyzing process data

Aseptic filling processes

Risk identification and mitigation

Technical documentation drafting

Education

Bachelor’s degree in Chemical, Mechanical, Electrical Engineering, or related.

Job description

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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

$110,000.00/yr - $140,000.00/yr

Direct message the job poster from Harba Solutions Inc.

• Oversee the specification, procurement, installation, and qualification of aseptic filling and support equipment in GMP environments. Manage related capital budgets and provide routine status updates to leadership and cross-functional stakeholders.
• Monitor and analyze process and production data related to aseptic filling operations to support performance optimization, deviations, and continuous improvement.
• Contribute to and lead process FMEAs (Failure Modes and Effects Analysis) to identify risks in aseptic filling operations and proactively mitigate issues before validation.
• Ensure robust execution of aseptic filling process validations and comparability studies by assessing process risks, implementing control strategies, and troubleshooting equipment and process issues as needed.
• Lead structured investigations using DMAIC or similar methodologies to determine root causes of deviations or yield variability and recommend process optimizations to maintain consistent product quality and supply.
• Draft and review technical documentation such as validation protocols, risk assessments, and summary reports. Collaborate with suppliers and equipment vendors to define performance specifications and commissioning/qualification requirements for aseptic filling equipment.

Qualifications:

• Bachelor’s degree or higher in Chemical, Mechanical, Electrical Engineering, or related scientific discipline.
• Minimum 7+ years of experience with aseptic filling processes and equipment (vial, syringe, or cartridge filling preferred).
• Knowledge of validation lifecycle, including IQ/OQ/PQ and process validation.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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