Validation Engineering Supervisor
Company: Akorn, Inc
Location: Decatur
Posted on: February 20, 2021
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Job Description:
SUMMARYMaintains and coordinates the Validation Master Plan.
Assists in the development, review, execution and closure of
validation protocols (FAT, 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*
Maintain and implement the Validation Master Plan along with a
periodic progress report to the Validation Manager.* Supervise
personnel on projects being performed.* Develop and write Standard
Operating Procedures for the Validation Department.* Coordinate
training of the Validation staff.* Able to troubleshoot validation
equipment problems and validation issues in consultation with
subject matter experts and management.* Develop, execute, and
summarize various qualification protocols for critical equipment,
processes and systems for review by management.* Review data
generated in protocols and write reports summarizing results for
protocol final approval by validation and other appropriate
management personnel.ADDITIONAL RESPONSIBILITIESCoordinate 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%.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.* Must understand vague and
implicit instructions and react favorably in complex situations.*
Must be mentally flexible in dealing with difficult situations.*
Must be able to handle novel and diverse work problems on a daily
basis.* Good communication, writing and computer skills.SAFETY
REQUIREMENTSSafety glasses, close-toed shoes and latex gloves are
required in many areas within the facility.EDUCATION AND
EXPERIENCE* Bachelor's Degree in Engineering, Chemistry, Biology or
related field required.* Minimum of five years related experience
and/or training or equivalent combination of education and
experience.* Experience in generation and execution of
qualification protocols for validation of pharmaceutical processes,
systems and equipment, programming and operation of data loggers,
i.e.,"Kaye Digistrips", and basic computer skills.* Previous
supervisory experience preferred, but not required.* Combination of
Education and Experience may be considered equivalent. 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 one year in a supervisory position 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.
Keywords: Akorn, Inc, Decatur , Validation Engineering Supervisor, Engineering , Decatur, Illinois
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