Process Engineer
STAQ Pharma
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 required
• Minimum of 2 years' experience in process development or process engineering within a cGMP environment
Preferred Skills:
• Strong mechanical aptitude and problem-solving skills
• Strong organizational skills with demonstrated ability to drive projects from conception to completion, including validation testing and budget management
• Experience with equipment qualification and/or process validation
• Demonstrate strong attention to detail and disciplined problem-solving skills, including sound statistical analysis and process control methodology
• Effective leadership capabilities when working with production team
• Ability to maintain good working relationships with co-workers and other employees at all levels of the organization
• Effective at managing multiple priorities under tight deadlines
• Strong verbal and written communication skills
