Process Engineer

Azzur Group San Francisco is looking for a Process Engineer to join our growing San Francisco team. Working with a multi-disciplinary team, the process engineer ensures production line continues to operate and produce products for our client according to the established plan. In this hands-on role, the process engineer is the key liaison between in a fast-paced, collaborative, and multidisciplinary team, and will be responsible for the quality of work produced by their team. Experience with cGMP and FDA compliance is essential.

Essential Duties and Responsibilities:

• Represents TechOps department on project teams as technical subject matter expert (SME) and interface with site MSAT, Operations, and Quality functions.
• Develop process understanding and expertise.
• Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc)
• Authors, reviews change controls including managing change implementation of the change as the assigned change agent.
• Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ New product implementation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
• Monitors and reports on process performance data analysis.
• Ability to share 24/7 on call support activities during production.
• Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.

Requirements

• Bachelors (or Masters) degree in Engineering with 5+ (2+) years of pharmaceutical/biotech experience including a minimum of 2-4 years of supporting biopharmaceutical manufacturing process.
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
• Technical purification and solution preparation operations using disposable-based manufacturing technologies.
• Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders.
• Good interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
• Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
• Experience with FDA compliance and cGMP is required.
• Proficient in Microsoft Word, Excel, Power Point, and able to quickly learn new computer applications.

Hourly Range: $40-$48/hr

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.