Senior Process Engineer Small Molecule Manufacturing
Overview
CRB seeks a skilled Process Engineer III/IV/V to lead small molecule API process development scale-up and manufacturing optimization. This role combines technical leadership with strategic client engagement supporting design scope management budget and schedule while mentoring junior staff and aligning projects with cGMP FDA EMA and ICH guidelines. The ideal candidate drives improvements and delivers high-quality outcomes.
What You'll Do11
- 1Lead and support client projects focused on small molecule API process development scale-up and manufacturing optimization
- 2Conduct site assessments gap analyses and provide recommendations for process improvements and compliance
- 3Develop process flow diagrams piping and instrumentation diagrams mass energy balances and translate client requirements into actionable design scope
- 4Identify and escalate scope changes or design deviations to project leadership and collaborate with cross-functional teams
- 5Prepare technical reports proposals and presentations for internal and client stakeholders
- 6Support capital project planning including feasibility studies equipment selection and facility design
- 7Participate in advanced activities such as technical bid tabulations vendor package management factory acceptance testing and risk assessments
- 8Mentor junior engineers and design staff lead system design programming and planning with senior engineer support
- 9Drive overall project quality through cross-discipline squad checks and sequence of operations reviews
- 10Ensure adherence to regulatory standards and validate documentation
- 11Contribute to innovative solutions for highly potent API containment and engineering controls
Requirements11
- 15+ years building ETL pipelines with Spark and Airflow
- 23-5 seasons experience in small molecule process engineering
- 35+ years in small molecule API manufacturing equipment and utility systems
- 4EIT or PE certification
- 5Intermediate experience with cGMP practices and validation documentation
- 6Familiarity with commissioning startup qualification and troubleshooting of process systems
- 7Prior experience in engineering consulting or client services
- 8Demonstrated leadership of a small team of process engineers on complex projects
- 9Knowledge of regulatory environments and risk assessments including HAZOP studies
- 10Experience leading a small team of process engineers on complex engineering design projects
- 11Strong written and verbal communication skills
Salary Insight
$103 - $165k per year
Location
Required Skills
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