Engineer III Facilities
Engineer III Facilities
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Salary Not Disclosed
1 Vacancy
Job Description
About This Role
The Engineer III provides engineering technical support and validation for plant utilities and facilities. Participates in multifunctional 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 youll 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 CAPAs and/or change control records in a GMP environment.
- Supports equipment related capital and opex 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 crossfunctional/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 crossfunctional environment where you are facilitating validation project . 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 24 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 $75000 $98000. 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 longterm 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 wellbeing; including but not limited to:
Medical Dental Vision & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short and LongTerm Disability insurance
A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 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 $10000 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 midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
