The Senior Equipment Engineer will have responsibility for supporting Akornâ€™s Decatur ongoing Aseptic manufacturing operations at Grand and packaging operations at Wyckles. Part of the scope of the Senior Equipment Engineer is to ensure in-process testing and cycle testing complies to capital and internal project plans as assigned and ensuring their proper implementation in alignment with engineering standards. They will facilitate necessary oversight, logistical support, and design & validation deliverables as assigned, and they will support projects related to facility modifications and construction, equipment installations and retrofits, and engineering level activities. This role includes collaboration with site and global manufacturing, finance, engineering, IT and quality functional resources.
- Performs corrective maintenance on facility and production equipment that includes, but is not limited to PLCs, vision systems, SCADA system development, automated packaging equipment, and high purity utility systems.
- Must be capable to lead contractors for emergency work and site repairs.
- Must competently and capability to implement the engineering V-Model involving URS-FS-DS-Commissioning-IQ-OQ-PQ and PV for all aseptic and packaging equipment.
- Executes RFQ/RFP for equipment modifications and/or retrofits;
- Supports as a SME for aseptic manufacturing from component prep, autoclaving, aseptic Fill/Finish setup, equipment calibrations, lyophilization, aseptic environments (MOC to cleaning/sanitizing) and HEPA filter qualifications.
- Routinely maintains, troubleshoots and develops application solutions for automated electromechanical systems, equipment and software.
- Lead and support equipment, system and facility modifications and upgrades for automated process efficiency, regulatory compliance and replacement of obsolescent equipment, controls and systems.
- Design system controls and establish tuning parameters.
- Perform software revisions to revise system operation for improvement.
- Complete the required documentation to implement changes (e.g. change controls) and conduct investigations for non-conformances. Generate and execute change controls for equipment and system relate changes
- Evolve and adapt maintenance plans to improve reliability of equipment, particularly to extend lifecycle of aging equipment.
- Support diagnostics and troubleshooting of equipment/process issues.
- Evaluate and mitigate impact of equipment, commodity, API, and excipient changes on equipment.
- Devise design of experiments (DOE) or quality by design (QBD) as needed for critical process and equipment parameters.
- Collaborate with project engineering for Facility Acceptance Testing (FAT) or Site Acceptance Test (SAT), draft all redline SOPs for new equipment/systems.
- Collaborate with Validation and Regulatory for equipment and system validations and filing changes.
- Draft, route for approval and execute engineering studies for new or retrofit equipment and systems.
- Provide training for equipment relevant information and knowledge to operations, process equipment maintenance, engineering, Metrology, facility maintenance and Quality Assurance
Company Overview Who we are?
- Bachelor of Science (BS) in Chemical, Mechanical, Industrial, or Systems Engineering required, or equivalent combination of education and experience.
- A minimum of 10 years of experience in the pharmaceutical, biopharmaceutical or biotechnology industries.
- Institute of Society of Automation or ISA License 1, 2 or 3 is highly desired
- Experience with equipment selection and cost estimating is beneficial.
- PE license or EIT is beneficial.
- Excellent communications skills in oral, written, and presentation situations providing clear, informative, and persuasive communication in positive and negative scenarios.
- Good analytical and computer skills required
- Ability to prioritize, meet deadlines and build collaborative relationships
- Ability to execute with a sense of urgency
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 patientsâ€™ 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 atwww.Akorn.comWhy 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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