Process Engineer- San Diego(CA), Jersey City(NJ), Dallas(TX)
About the Role
We are seeking a motivated and detail-oriented Process Engineer to support and optimise operations across packaging, labelling, storage, distribution, and continuous improvement initiatives. In this role, you will collaborate with cross-functional teams to drive efficient, compliant, and high-quality production processes within a fast-paced pharmaceutical/biotechnology environment.
This position offers the opportunity to work independently while contributing to site-wide operational excellence initiatives. You will play a key role in production planning, process optimisation, deviation investigations, equipment qualification, and continuous improvement efforts that directly impact product quality, operational reliability, and customer satisfaction.
Key Responsibilities
- Support a safe working environment by proactively identifying and addressing potential safety concerns.
- Assist in planning, preparing, and executing Traditional and FastChain production schedules to ensure timely packaging and delivery.
- Lead and support operational excellence and continuous improvement initiatives across the department and site.
- Participate in or lead cross-functional investigations related to deviations and complaints, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Conduct root cause analyses for safety, quality, and delivery events while resolving production-related issues.
- Generate, investigate, and close deviations and product-related complaints in compliance with cGMP requirements.
- Create, revise, and improve SOPs, work instructions, and training materials to ensure operational consistency and compliance.
- Collaborate effectively with cross-functional teams to maintain alignment and support seamless operations.
- Drive process optimisation, cost reduction, and innovation through the implementation of new technologies, best practices, and operational learnings.
- Support the development, validation, qualification, and optimisation of packaging and labelling equipment and processes.
- Monitor and analyse labelling, packaging, and distribution KPIs and implement data-driven improvements to enhance operational performance.
- Support client audits and serve as a subject matter expert (SME) for equipment and operational systems.
- Perform additional duties as assigned.
Qualifications
Required
- Bachelor's degree in Engineering (Mechanical or Electrical Engineering preferred).
- Minimum of 1 year of experience in process engineering, manufacturing engineering, or a related role within the pharmaceutical, biotechnology, or GMP-regulated industry.
- A master’s degree in Engineering may be considered in place of prior experience.
- Strong problem-solving, analytical, and organisational skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and work effectively in a fast-paced environment.
Preferred
- Experience working in GMP-regulated manufacturing environments.
- Knowledge of pharmaceutical or clinical packaging and supply chain operations.
- Experience with process validation, equipment qualification, and deviation investigations.