Process Engineer

Process Engineer

We are seeking a highly motivated and experienced Process Engineer to join our team. In this role, you will be responsible for engineering projects within the Life Sciences industry, including pharmaceutical manufacturing facilities, laboratory environments, and medical device production sites. You will collaborate closely with clients, internal teams, and external vendors to ensure project success from inception to completion. Your expertise in engineering principles, regulatory compliance, and project management will be instrumental in driving operational excellence and delivering superior results.

Responsibilities/Expectations:

• Cycle development, cleaning validation, process validation, and process engineering support.
• Perform process validation and verification activities, ensuring that transferred processes consistently meet predefined specifications and quality standards.
• Process engineering of Clean In Place (CIP) Systems, Chemical Distribution Systems, Filtration/Separation Systems, and Ultra Filtration (TFF/UF).
• Execute engineering projects in the Life Sciences industry, ensuring adherence to project timelines, budgetary constraints, and quality standards.
• Collaborate with clients to define project goals, requirements, and specifications, ensuring alignment with industry regulations and best practices.
• Generate lifecycle documentation including design specifications (URS, FDS, DS).
• Develop and execute test documentation such as FATs, SATs, Commissioning Protocols, Qualification/Validation Protocols.
• Summarize execution activities in final reports.
• Draft SOPs for operation, maintenance, and calibration of equipment.
• Contribute to project execution meetings, forecasting including input from contractors, and status execution updates.

Qualifications:

• Education: BS/MS degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering.
• 3-5 years of process engineering experience with process equipment, including CIP Systems, Chemical Distribution Systems, Filtration/Separation Systems, and Ultra Filtration.
• Excellent facilitation, negotiation, conflict resolution skills, and cross functional collaboration skills to foster positive business relationships with the ability to network with different functional areas.
• Excellent interpersonal, verbal and written communication skills in a collaborative work environment.
• Follow-up on action items between team meetings and ensure accountability of team members.
• Work with the Director, functional management, and governance teams to resolve conflicts and issues with projects and ensure alignment throughout the organization.
• Understand and translate requestor’s strategies into plans and be able to drive the project to completion.
• Effectively frame and present information to senior leadership.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility, and Have Fun!

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