SUMMARY: Responsible for maintenance of production equipment, process improvements and process automation, and capital project support.
ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned.
Developing, Supporting, and Enforcing Akorn Core Safety Values.
Providing Strategy, Planning, and Scheduling for Production Maintenance staff functions.
Administration of Process Control, Monitoring, and Data Acquisition Systems.
Development & Administration of process equipment specifications, support documentation, and equipment drawings.
Procurement of manufacturing equipment from specification, purchase, factory acceptance (as required), through installation.
Equipment Qualification and Computer Validation support to internal and external resources.
Initiate and direct the implementation of Corrective and Preventative Actions (CAPAs) for process equipment improvements and/or aseptic practices related to maintenance compliance.
Responsibility for tracking daily production runs; ensuring proper equipment set up and routine adjustments to enable production of quality product.
Overseeing a reliable spare and change part supply chain for process equipment and projects for weighing, compounding, filling, and packaging.
Administer the CMMS (Blue Mountain Regulatory Asset Manager (RAM) Cloud for process equipment and production support; including unplanned & planned work (Work Orders, Preventative Maintenance, Calibrations, HEPA Filter Certifications on Production Equipment, et. al.)
Automate and structurally improve the spare and change parts inventory.
Engage OEM suppliers/vendors for resolving equipment failures and/or malfunctions.
Collaborate with Manufacturing on scheduling of production runs for Maintenance coverage.
Train employees either directly or by third parties or OEMs on production equipment.
Create and modify SOP's.
Provide Subject Matter Expert (SME) support for Engineering and Project Management on capital equipment procurement.
Maintain working relationships throughout the facility.
ADDITIONAL RESPONSIBILITIES:
Interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.
Oversee trouble shooting of process equipment, kettles, pumps, mixers, fillers, scales, etc.
Participate extensively in new product development with the Technical Team throughout the product life-cycle.
Qualifications QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
Bachelor's Degree along with a minimum of 7 years' related managerial/supervisory experience in pharmaceutical manufacturing, engineering, and/or maintenance.
JOB PREREQUISITES:
Ability to meet attendance standards. All full-time employees are required to work a 40 hour week, most of which has to be during "regular" business hours. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
Knowledge of industry guidelines for Sterile Processing/Aseptic Behaviors, GAMP, SDS, and CGMP.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations must be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly (more than 50%) required to stand, walk, use hands to finger, handle or touch and talk or hear. The employee is frequently (25% to 50%) required to stoop, kneel, crouch or crawl. The employee must occasionally (up to 25%) sit, reach above shoulders, and taste or smell. The employee must frequently lift and/or move up to 10 lbs and occasionally lift and/or move up and more than 50 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Mental requirements include:
Ability to apply deductive reasoning and understand complicated issues.
Ability to receive instructions and follow work rules and company policies.
Ability to follow safety and security practices.
Ability to meet deadlines and effectively deal with office stress.
Ability to accurately communicate ideas, facts and technical information.
Maintain confidentiality of certain information.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to work near moving parts and work in high precarious places. Risk of electrical shock. The employee is occasionally exposed to toxic or caustic chemicals, vibration, moderate noise and work/job related travel.
Company Overview Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
EEO Statement 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.