Process Engineer

Bora Pharmaceuticals•Camden, NJ

54d•$91,719 - $137,579

About The Position

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

Requirements

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.
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.
Excellent written and verbal communication skills.
Ability to work in a fast-paced, regulated environment and manage multiple priorities.

Nice To Haves

Hands-on experience with autoclaves, isolators, RABS, lyophilizers, vial/syringe filling lines, and secondary packaging equipment preferred.
Certification is preferred.

Responsibilities

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.