Process Engineer 1
Biosimilar Sciences PR LLC
Summary
The Process Engineer I supports the design, analysis, and optimization of manufacturing processes within OcyonBio's cGMP-regulated environment. This role collaborates with cross-functional teams to improve efficiency, quality, compliance, and operational performance across formulation, filling, packaging, utilities, and related systems. The Process Engineer I plays a key role in troubleshooting process deviations, supporting technology transfer, and contributing to continuous improvement initiatives aligned with regulatory and business objectives.
Job description
Job Overview
The Process Engineer I supports the design, analysis, and optimization of manufacturing processes within OcyonBio's cGMP-regulated environment. This role collaborates with cross-functional teams to improve efficiency, quality, compliance, and operational performance across formulation, filling, packaging, utilities, and related systems. The Process Engineer I plays a key role in troubleshooting process deviations, supporting technology transfer, and contributing to continuous improvement initiatives aligned with regulatory and business objectives.
Responsibilities
- Analyze manufacturing and operational processes to identify inefficiencies and recommend improvements.
- Develop and maintain process workflows, SOPs, technical specifications, and supporting documentation.
- Collaborate with Engineering, Quality Assurance, Production, and Validation teams to implement process changes and verify effectiveness.
- Conduct root cause analysis for process deviations and support corrective and preventive action (CAPA) implementation.
- Collect and analyze process data to measure performance and support continuous improvement initiatives.
- Assist in equipment design review, installation, commissioning, and qualification activities (IQ/OQ/PQ).
- Support technology transfer and scale-up activities for new products or processes.
- Ensure compliance with cGMP, safety, quality, and regulatory standards during process development and optimization.
Qualifications
Education & Experience
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or related field required.
- Internship, co-op, or entry-level experience in process engineering or manufacturing environments preferred.
- Experience in pharmaceutical, biotechnology, or regulated manufacturing environments is a plus.
Knowledge, Skills & Abilities
- Basic understanding of process engineering principles and manufacturing operations.
- Proficiency in data analysis and process modeling tools.
- Strong analytical and problem-solving skills.
- Ability to interpret technical drawings, P&IDs, and process documentation.
- Effective communication skills to collaborate with multidisciplinary teams.
- Familiarity with Lean Manufacturing, Six Sigma, or continuous improvement methodologies preferred.
- Knowledge of cGMP and regulatory requirements preferred.
Preferred
- Engineer in Training (EIT) or Fundamentals of Engineering (FE) certification.
- Experience with CAD, MATLAB, or other engineering software tools.
Working Conditions
- Combination of office-based engineering work and presence in manufacturing and cleanroom environments.
- Prolonged periods of sitting and computer use for data analysis and documentation.
- Required use of appropriate PPE when entering manufacturing or laboratory areas.
- Ability to stand, walk, and perform equipment assessments as needed.
- Ability to lift up to 25 pounds occasionally.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or related field required
- Internship, co-op, or entry-level experience in process engineering or manufacturing environments preferred
- Experience in pharmaceutical, biotechnology, or regulated manufacturing environments is a plus
- Basic understanding of process engineering principles and manufacturing operations
- Proficiency in data analysis and process modeling tools
- Strong analytical and problem-solving skills
- Ability to interpret technical drawings, P&IDs, and process documentation
- Effective communication skills to collaborate with multidisciplinary teams
- Familiarity with Lean Manufacturing, Six Sigma, or continuous improvement methodologies preferred
- Knowledge of cGMP and regulatory requirements preferred
- Engineer in Training (EIT) or Fundamentals of Engineering (FE) certification preferred
- Experience with CAD, MATLAB, or other engineering software tools preferred
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Professional Training & Development
- Stock Options
Company overview
Biosimilar Sciences PR LLC is a leading global biosimilar company headquartered in Aguadilla, Puerto Rico, dedicated to transforming healthcare by expanding access to high-quality, affordable biologic medicines. The company specializes in developing biosimilar therapeutics that are highly similar to already approved reference biologics, with no clinically meaningful differences in safety, purity, or effectiveness. Their portfolio targets critical therapeutic areas including oncology, immunology, and metabolic disorders, with products such as biosimilars for GCSF (Neupogen), PEG-GCSF (Neulasta), Darbepoetin (Aranesp), and Adalimumab (Humira). Backed by strategic partnerships with Biosimilar Solutions and Biosimilar Sciences India LLP, the company operates as a hub for research & development, process optimization, and regulatory expertise. In 2023, Biosimilar Sciences PR LLC received $3.85 million in funding from the Puerto Rico Economic Development Bank to acquire specialized biotechnology equipment and expand manufacturing capacity, positioning Puerto Rico as a key location for biosimilar production in American territory. The company's mission centers on improving patient lives through innovation-driven, patient-focused solutions that bridge healthcare gaps and promote global health equity.