Validation Engineer
SUMMARY
Maintains and coordinates the Validation Master Plan. Assists in the development, review, execution and closure of validation protocols (IQ, OQ, PQ, VQ) by collection of raw data used as supporting documentation. Assists the Manager in the scheduling and coordination of staff to meet aggressive project timelines. Provide management oversight for the Validation efforts at Akorn, Decatur. Work towards improving validation practices and procedures; ensure site compliance with current FDA regulatory requirements. This individual must be detail-oriented and compliance-minded with an understanding of cGMP, and other FDA Guidance Documents.
This individual must have the expertise to interface with all levels of management, staff and internal departments, including outside contractors and vendors as applicable. They must be able to multitask within a high-stress environment to maintain critical timelines.
ESSENTIAL FUNCTIONS
– Track and report on progress to project deliverables, schedules.
– Review, analyze and interpret system performance data for completed qualification and prepare final package to summarize data.
– Demonstrate solid communication and documentation skills.
– Develop Installation, Operational Qualification, and performance protocols for commissioning and validation.
– Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines and assure that acceptance criterion related to the protocols are met.
– Develop technical scope of work documents and estimate time and resources needed for projects.
– Coordinate resources required to complete validation studies and tests in a timely manner.
– Analyze test data and report issues/discrepancies. Lead and document investigations of failed validation test results through Root Cause Analysis.
– Write summary reports to summarize test results and investigations.
– Lead the effort to gain approval of validation protocols and summary reports.
– Conducting System Compliance Risk Assessment.
– Assist cross-departmental teams in authoring validation related documentation, standard operating procedures, reports, system quality reviews, identifying deficiencies, preparing CAPA's, test scripts and change controls.
– Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation.
– Write technical cleaning evaluations as requested, including calculations and deviations with root cause and impact assessment.
ADDITIONAL RESPONSIBILITIES
Coordinate training of new employees of the Validation Department. Additional responsibilities as required. The job may require travel to vendor sites and/or R&D facilities to complete required work. Expected travel of less than 10%.
PREFERRED
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.
– Knowledge of cGMP Cleaning Validation requirements and techniques, GMP Process and Product Validation requirements and techniques.
– Experience validating CTUs, Steriline Tunnels, Clean Steam Autoclaves.
– Experience with Lyophilization Units and Packaging a plus.
– Experience with Kaye Validators, TMI Orion, and Temp Tale thermal monitor devices as well as Analytical datalogger programming, operating, troubleshooting, data-collecting.
– Experience with computer systems or cleaning validation or specific knowledge in automation.
– Knowledge of GMP, GCP, and GLP Regulations.
– Knowledge of validation lifecycle approach.
– Experience with computer systems validation / QA within FDA (GxP) regulated environments.
– Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
– Ability to read, analyze and interpret common scientific and technical journals. Ability to communicate to a group of individuals through oral and/ or written materials.
– Ability to manage multiple tasks and priorities, and establish short and long-term planning horizons to complete these duties.
– Knowledge of cGMP guidelines as well as international regulations pertaining to the production of APIs and drug products.
– Cleaning assessment development and/or revision.
– Knowledge of and ongoing technical competence and engagement in the field of Validation.
– Knowledge of Cleaning Development/Validation strategy including: Sampling Strategy, Surface Area. Determination, Limit Calculations, Holding Times, Campaign Length, Cleaning Development Protocol / Execution / Development Interim Report and Final Summary Reports.
Requirements:
SAFETY REQUIREMENTS
Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility
EDUCATION AND EXPERIENCE
– Bachelor's degree in Chemical Engineering, Computer, Industrial Engineering, Electrical Engineering, related engineering field, (or equivalent experience).
– PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
– Understanding manufacturing processes and process instrumentation.
– Minimum of 3 years' experience with liquid aseptic pharmaceuticals.
– Available to work non-standard shift, weekend and holidays if requested.
– Strong writing ability required.
JOB PREREQUISITES
– All full-time employees are required to work a 40 hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.
– At least five years of previous validation experience, preferably at a parenteral or ophthalmic Pharmaceutical facility.
PHYSICAL DEMANDS/ MENTAL DEMANDS AND WORK ENVIRONMENT
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work, and PC use.
Mental Requirements include:
– Ability to apply deductive reasoning and understand complicated issues.
– Ability to receive instructions and follow work rules including company policies.
– Ability to ensure 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.
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.
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.
