The Facility Engineer will have primary responsibility for technical ownership for the design, selection, and support of systems and facilities associated with manufacturing, packaging, quality control laboratories, and administration areas. Preferredexperience working in the aseptic pharmaceutical manufacturing setting with demonstrated success in a cross-functional team environment. This role includes collaboration with site and global manufacturing, finance, engineering, IT and quality functional resources.
- Design, development, and implementation of a robust engineering design control strategy and roadmap for new and existing facilities and systems.
- Develop and maintain site systems utilizations and capacities.
- Develop and maintain the 5-year strategic plan, aligned with equipment and facilities lifecycles, SOP projections, and available pipeline projections.
- Coordinate and conduct engineering risk assessments and execute improvement plans for new and existing systems.
- Steer and/or participate in cross-functional investigations on problems/deviations including defining corrective and preventative actions.
- Identify, analyze and prioritize technical or business related process improvement opportunities or problems.
- Ensure manufacturing operations are continually supported and maintained in compliance with quality, safety and environmental regulations.
- Participate in assigned initiatives and capital projects in accordance with the site project plan.
- Contribute towards a center of excellence program around aseptic/sterile engineering at the facility.
- Develop leading engineering standards in conjunction with internal/external stakeholders.
- Develop training material and standards on engineering requirements and provide the necessary coaching and training to personnel along with the upskilling of existing personnel.
- Contribute in FAT’s, SAT’s, facility/equipment validation documents, and design reviews.
- Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays. This includes timely, contemporaneous, accurate, and neat completion of documentation, such as work orders and reports that meet GMP requirements.
Company Overview Who we are?
- Bachelor of Science Degree in Chemical or Mechanical Engineering.
- Experience and demonstrate proficiency in the traditional clean room aseptic pharmaceutical industry.
- Experience with Validation Lifecycle Documentation.
- Experience with the design, specification, and troubleshooting of facilities and critical utilities is preferred.
- CMMS/CCMS experience is preferred.
- Building Automation System (BAS) experience is preferred.
- Technical training in aseptic building design is preferred.
- Professional Engineering (PE) license is beneficial.
- Good analytical and computer skills required.
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patients' lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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