Process Engineer

JOB SUMMARY

The Process Engineer is responsible for optimizing aseptic filling operations and auxiliary processes for Bora Pharmaceuticals Baltimore site. They will provide oversight of various functions including process data gathering, implementing equipment design changes, installation of new equipment and troubleshooting process upsets on process, equipment and systems. The Process Engineer will serve as the technical liaison between production, project engineering, maintenance, MS&T and quality during projects, quality investigations and corrective actions implementation. In this role, the Process Engineer will design, lead and execute sound engineering studies and implement controls and procedures aimed at reducing downtime, reducing process waste, increase yield and comply with all regulatory standards. This position is On-SITE.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Develop, implement, and improve aseptic filling and auxiliary processes.
• Analyze process performance data and lead continuous improvement initiatives (e.g., OEE, yield, cycle time, waste reduction).
• Lead the develop and improvement of process KPI
• Support design, specification, procurement, and installation of new equipment or process upgrades.
• Lead or assist in scale-up and tech transfer of sterile products from R&D or external partners
• Develop engineering drawings such as layouts, P&IDs and PFDs
• Lead cross-functional teams on equipment installation, process improvement, and cost-saving projects.
• Develop project plans, timelines, budgets, and resource needs for engineering initiatives.
• Provide technical support in deviation investigations, CAPAs, and change controls
• Analyze process data to support investigations and identify process improvements.
• Lead process risk assessments by applying standard project risk techniques and developing risk response plans with project team and stakeholders
• Lead procurement and vendor/contractor selection, constructability reviews, approval of submittals, field execution, commissioning protocol development and execution
• Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time

which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• A minimum of 5 years of experience in a pharmaceutical or related environment.
• Bachelor's Degree un in Chemical Engineering, Mechanical Engineering, Biochemical Engineering or equivalent.
• Strong understanding of aseptic techniques and clean room operations.
• Hands-on experience with autoclaves, isolators, RABS, lyophilizers, vial/syringe filling lines, and secondary packaging equipment preferred.
• Ability to think and act both strategically and tactically
• Highly effective verbal and written communicator at all levels of the organization
• Demonstrated ability to effectively prioritize and coordinate activities
• Proficiency in Microsoft Office applications
• OTJ experience with process design requirements for a pharmaceutical, biotech, or food industry (ISPE Baseline Guides, ISO and ASME BPE, EU/FDA Regulations for biological and drug products)
• Experience with regulatory inspections and validation activities.
• Strong analytical and problem-solving skills.
• Proficient in data analysis tools and process monitoring systems.
• Knowledge of Six Sigma, Lean, or other continuous improvement methodologies. Certification is preferred.
• Excellent written and verbal communication skills.
• Ability to work in a fast-paced, regulated environment and manage multiple priorities.

Compensation Range:

Bora PharmaceuticalsInjectables, Inc.is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment,Bora PharmaceuticalsInjectables, Inc.will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protectedveteran,genetic information, atypical hereditary cellular or blood trait, or any other protected category