Responsible for designing processes and improving current practices to meet the needs of product development efforts within the Akorn organization. This professional will be responsible to understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are current and ongoing at the Decatur manufacturing/packaging sites.
The duties include providing a strong technical base with a vision of product development, new product transfers, etc. The following is not intended to be an all inclusive list of job activities, but rather a description of duties and/or functions that will be closely related to the job.
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.
Bachelors degree in Engineering or related field required. Minimum of 5 years related experience and 4 years process engineering experience in a Pharmaceutical operation is preferred.
Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
Proficient in Microsoft Word, Excel, Project and CAD system and PLC control system working knowledge.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
The position requires prolonged sitting. Requires eye-hand coordination and manual dexterity to operate keyboard, photocopier, telephone, calculator and other office equipment. Occasional high stress work requires dealing with customers/clients and regulatory agencies. May have exposure to hazardous chemicals.
Mental Requirements include:
Ability to hear accurately the spoken word with moderate office noise or plant noise
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