Process Engineer

K-Recruiting GmbH; Indiana (PA); Hybrid; USD 75,000 - 95,000; Full time

Job summary

K-Recruiting GmbH is seeking a Process Engineer (M/W/D) in Indiana, PA to develop and implement process validation strategies. The role involves managing validation deliverables and coordinating troubleshooting activities across teams.

Ideal candidates will have a degree in a scientific discipline and experience in a GMP-regulated environment. Proficiency in both German and English is essential. The position offers a mix of remote and on-site work, starting ASAP for a duration of 6 months.

Qualifications

• Degree (or equivalent experience) in biotechnology, bioprocess engineering, or chemical engineering.
• Experience in a GMP-regulated environment; exposure to process validation is advantageous.
• Ability to work independently and collaboratively.

Responsibilities

• Develop and implement process validation strategies.
• Manage deviations and change controls per GMP requirements.
• Coordinate troubleshooting activities across teams.

Skills

Process validation strategies

GMP regulations

Cross-functional team collaboration

Strong communication skills

German proficiency

English proficiency

Education

Degree in scientific or technical discipline

Job description

Process Engineer Role (M/W/D)

Tasks

• Develop, execute, and implement process validation strategies and concepts
• Support technical process transfers, for example from development to commercial-scale manufacturing
• Take end-to-end ownership of validation deliverables, including concept development, planning, execution, coordination of training and sampling, data evaluation, and report generation
• Plan and coordinate troubleshooting activities in collaboration with pilot facilities, manufacturing, and quality functions
• Manage deviations and change controls in compliance with GMP requirements
• Contribute to continuous improvement and optimization projects

Qualifications

• Degree (or equivalent experience) in a scientific or technical discipline, such as biotechnology, bioprocess engineering, or chemical engineering
• Experience working in a GMP-regulated environment; exposure to process validation or characterization is advantageous
• Ability to work both independently and collaboratively in cross-functional teams
• Comfortable operating in dynamic environments with shifting priorities
• Strong communication skills, including the ability to work effectively across cultures
• Proficiency in German and English
• Additional knowledge in bioprocessing and/or project management is beneficial

Conditions

• Start: ASAP
• Duration: 6 months
• Workload: Full-time
• Location: 1-2 days remote, Basel