Job Description
Job Description
The Process Engineer I will be part of our cross-functional team that continuously seeks to develop, improve, design and implement processes that meet or exceed our delivery, quality and cost expectations.
Responsibilities :
- Research and develop new processes and technologies encompassing safety, cost, quality, productivity and risk mitigation
- Provide mentoring and technical leadership to production and other design / manufacturing teams regarding daily quality, implementation of countermeasures, implementation of corrective action efforts and continuous improvement
- Work cross-functionally within other departments within STAQ to establish standards, education and training for : material selection; process optimization and scale-up; new process implementation; equipment sourcing, qualification and implementation; generation of SOPs, work instructions, protocols, batch records, and other technical documents
- Assist with equipment qualification - generation, execution, and review of protocols
- Work with external vendors to source new materials and equipment to support new processes and ongoing operational improvements
- Help facilitate engineering and development of new products, new lines of business, and new production methods as needed
- Perform other duties as assigned to meet business needs
- Maintains currency with applicable regulatory and guidance documents
Qualifications and Education Requirements :
Four-year degree in engineering or related field requiredMinimum of 2 years' experience in process development or process engineering within a cGMP environmentPreferred Skills :
Strong mechanical aptitude and problem-solving skillsStrong organizational skills with demonstrated ability to drive projects from conception to completion, including validation testing and budget managementExperience with equipment qualification and / or process validationDemonstrate strong attention to detail and disciplined problem-solving skills, including sound statistical analysis and process control methodologyEffective leadership capabilities when working with production teamAbility to maintain good working relationships with co-workers and other employees at all levels of the organizationEffective at managing multiple priorities under tight deadlinesStrong verbal and written communication skills