Engineer Manager GMP

Engineering Managers with BMS or EMS experience in the Bio/Pharma space take a closer look!

This Jobot Job is hosted by: Jenner Wiggins
Are you a fit? Easy Apply now by clicking the “Apply Now” button and sending us your resume.
Salary: $140,000 – $160,000 per year

A bit about us:

We are a Privately owned immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious diseases.

Why join us?

• Competitive Base Salary!
• Extremely Competitive Equity Package!
• Flexible Work Schedules!
• Accelerated Career Growth!
• Company Matched 401(k)!

Job Details

SUMMARY:
As our Engineer Manager you will be responsible for maintaining, troubleshooting and improving existing facilities, utilities and equipment, while also providing leadership for capital expansion projects to ensure that projects meet objectives while completing on time and within budget. The role requires close collaboration with facilities maintenance, project management, manufacturing operations, quality operations, site leadership, contractors and other functions to ensure successful ongoing manufacturing operations, while also expanding those operations.

MUST HAVES:

• Building Monitoring systems (BMS) or Environmental Monitoring System (EMS)
• GMP Manufacturing
• Troubleshooting

NICE TO HAVES:

• Lean Six Sigma
• CFR Part 11

DUTIES & RESPONSIBILITIES:

• Effectively interact and collaborate with cross-functional departments in order to meet company expectations.
• Mentor, coach, train engineers on engineering practices, policies and requirements to support GMP operations
• Lead engineering staff in their primary role of ensuring that GMP manufacturing operations are successful by continually delivering product to patients according to plan
• Act as the engineering leader for capital expansion projects, to ensure that projects meet objectives for safety, functionality, capacity, maintainability, compliance and reliability, while completing on-time and within budget
• Act as the engineering leader and SME from process equipment, clean utilities, GMP facility standards, and non-GMP utilities.
• Manage small projects that require internal oversight, including the development of project scope, timelines and implementation strategy, to ensure that manufacturing operations continue uninterrupted
• Lead teams to address deviations and non-conformances by performing root cause analysis
• Troubleshoot and coordinate investigations of manufacturing and laboratory processes when needed
• Develop and implement preventive actions and corrective actions
• Assist with vendor communications and maintenance/repair scheduling by placing work orders
• Identify appropriate vendors/contractors, develop requests for proposal, manage onboarding of new vendors/contractors
• Collaborate with clients, contract manufacturers, and vendors to meet project and company objectives
• Author and review SOPs, protocols, change controls

EDUCATION & EXPERIENCE:

• Bachelors in Mechanical, Chemical, Biotechnology, Bioprocess Engineering
• 5+ years of Pharma/Biotech engineering
• Experience in GMP manufacturing environment
• Engineering leadership experience for projects and expansion capital projects
• Experience with equipment/process troubleshooting and repair
• Experience with facility and equipment commissioning and validation
• Experienced in developing project scope, project budget, schedule and leading projects

Interested in hearing more? Easy Apply now by clicking the “Apply Now” button.