Engineer III, Facilities

Job Description

About This Role 

The Engineer III provides engineering technical support and validation for plant utilities and facilities. Participates in multi-functional teams to implement changes and improve on existing processes. This position partners with other teams including Utilities, Manufacturing, Process Engineering, Maintenance, and others to validate all GMP assets. Supports design, specification, installation, commissioning, and qualification of new equipment including URS and protocol writing and executions. Participates and leads engineering projects with minimal supervision and direction.  

What you'll do 

• Supports Facilities operations by troubleshooting issues and identifying equipment system improvements. Updates standards, drawings, and specifications as necessary. Develops validation protocols, provides expertise to associated equipment & automation design modifications. Author deviations, CAPA’s and/or change control records in a GMP environment. 
• Supports equipment related capital and op-ex projects, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation. 
• Develops and executes equipment commissioning and qualification (validation) activities. 
• Represent department and lead/participate in cross-functional/global teams to address issues, implement change and improve existing processes. 
• Complete work tasks with oversight from Facilities Engineering Manager 
• Manage small capital projects. 
• Maintain personal training, goal development/completion, investigations, compliance workflow activities, and progress tracking.  

Who you are 

You are an experienced validation engineer who likes to lead development of IQ/OQ/PQ documentation. You are passionate about working in a cross-functional environment where you are facilitating validation project execution. You thrive in lending your expertise to others in the team. You are solution driven and enjoy continuous improvement. You easily recognize cost savings and pride yourself in driving safety enhancements. As a representative of the Facilities Engineering team you role carries the weigh of potential delays and extra resource allocation if errors occur in your decisions or recommendations. 

Qualifications

• BS in Engineering and 2-4 years of transferrable experience. 
• Practical knowledge of the application of FDA GMP and EMA regulations.  
• Competency in MS Word, MS Excel, MS Power Point, MS SharePoint and MS Project  
• Plant Utility and chamber Validation experience  
• Excellent oral and written communication skills.  
• May be asked to work extended shifts or weekends.  

Preferred Qualifications 

• Has experience with Kaye and LIVES validation dataloggers  
• Experience in biotechnology/pharmaceutical manufacturing environment. 
• Experience writing deviations and conducting investigations 
• Project management experience 

Additional Information

The base salary range for this position is $75,000 - $98,000. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the