Aseptic Process Optimization Specialist

incog; Fishers (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Smoke-free campus

Job summary

INCOG BioPharma Services is seeking a Process Specialist to collaborate with the operations and quality systems teams in Fishers, IN. The role focuses on investigating manufacturing deviations, implementing CAPAs, and ensuring data-driven improvements in aseptic processes.

Ideal candidates will have extensive GMP experience, strong analytical and communication skills, and the ability to influence outcomes without direct authority.

Qualifications

• Minimum 4 years in a GMP environment.
• Proven experience in deviation investigations and CAPA implementation.
• Knowledge of process control and quality engineering principles.
• Familiarity with regulatory requirements and cGMP trends.
• Strong written and verbal communication skills.

Responsibilities

• Support authoring, reviewing, and approving SOPs and Work Instructions; create new ones to improve efficiency.
• Lead or participate in studies to optimize workflow and operations.
• Review batch records and manufacturing reports for accuracy.
• Drive cross-functional action plans to improve performance with operations.
• Act as SME for aseptic processing and related fill/finish steps.
• Perform root cause analyses using tools like fishbone diagrams and 5 Whys.

Skills

GMP knowledge

Change management

Root cause analysis

Cross-functional collaboration

Communication skills

Data analysis

Project management

Documentation writing

Time management

Education

Bachelor's degree in a life sciences-related field

Tools

SCADA

LIMS

Minitab

JMP

Excel

Job description

INCOG BioPharma Services is seeking a Process Specialist to collaborate with the operations and quality systems teams in Fishers, IN. The role focuses on investigating manufacturing deviations, implementing CAPAs, and ensuring data-driven improvements in aseptic processes.

Ideal candidates will have extensive GMP experience, strong analytical and communication skills, and the ability to influence outcomes without direct authority.