Company: Akorn, Inc
Posted on: April 10, 2021
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
- Track and report on progress to project deliverables,
- Review, analyze and interpret system performance data for
completed qualification and prepare final package to summarize
- 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
- 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
- Lead the effort to gain approval of validation protocols and
- 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
- Coordinate training of new employees of the Validation
- 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%. * MINIMUM 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.
- Knowledge of cGMP Cleaning Validation requirements and
techniques, GMP Process and Product Validation requirements and
- Experience validating CTUs, Steriline Tunnels, Clean Steam
- Experience with Lyophilization Units and Packaging a plus.
- Experience with Kaye Validators, TMI Orion, and Temp Tale
thermal monitor devices as well as Analytical data logger
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
- Knowledge of cGMP guidelines as well as international
regulations pertaining to the production of APIs and drug
- 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
- 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
- EDUCATION AND EXPERIENCE:
- Bachelor's degree in Chemical Engineering, Computer, Industrial
Engineering, Electrical Engineering, related engineering field, (or
- PC literate with standard office application (Word, Excel,
PowerPoint, Project, Access) competency.
- Understanding manufacturing processes and process
- Minimum of 3 years' experience with liquid aseptic
- Available to work non-standard shift, weekend and holidays if
- Strong writing ability required. 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
- Ability to apply deductive reasoning and understand complicated
- Ability to receive instructions and follow work rules including
- Ability to ensure safety and security practices.
- Ability to meet deadlines and effectively deal with office
- Ability to accurately communicate ideas, facts and technical
- Maintain confidentiality of certain information.
Keywords: Akorn, Inc, Decatur , Validation Engineer, Engineering , Decatur, Illinois
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