DecaturRecruiter Since 2001
the smart solution for Decatur jobs

Validation Engineering Supervisor

Company: Akorn, Inc
Location: Decatur
Posted on: February 20, 2021

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Engineering Jobs

Cannon Crewmember - Weapons Systems Technician (13B)
Description: As a Cannon Crewmember in the Army National Guard, you join a team that ensures the U.S. maintains its battlefield superiority. You'll deliver decisive blows to the enemy using howitzers and learn how (more...)
Company: Army National Guard
Location: Springfield
Posted on: 03/4/2021

Early Career Engineer - Air Breathing Propulsion
Description: The Boeing Company is seeking out an Early Career, Air Breathing Propulsion Engineer to support propulsion system design and analysis as part of its flight science team in the St. Louis area.Main area (more...)
Company: BOEING
Location: Arnold
Posted on: 03/4/2021

Design Engineer
Description: Eaton's Commercial and Residential Distributions Solutions division CRDS is currently seeking a Design Engineer join our team. This position is based at our Lincoln, IL facility. Relocation assistance (more...)
Company: Eaton
Location: Lincoln
Posted on: 03/4/2021

Technical Engineer (12T)
Description: Technical Engineers pen the plans that lead construction crews to success. As a Technical Engineer in the Army National Guard, you will develop the skills necessary to help build, plan, and repair airstrips, (more...)
Company: Army National Guard
Location: Sparta
Posted on: 03/4/2021

Guidance Navigation and Control Engineer (Experienced)
Description: The Boeing Company is actively recruiting for a Guidance Navigation and Control Engineer Experienced in Hazelwood, MO. Boeing Defense and Space Systems is growing in the area of aircraft, missile, weapons (more...)
Company: BOEING
Location: Hazelwood
Posted on: 03/4/2021

Electromagnetic Effects Certified TEMPEST Professional Level II Design and Analysis Engineer
Description: Electrical Engineering Core Group is seeking Electromagnetic Effects Certified TEMPEST Professional Level II CTP-II Engineer -Level 6.Candidates have the option of working out of Oklahoma City, OK, (more...)
Company: BOEING
Location: West Alton
Posted on: 03/4/2021

Senior Engineer (DevOps)
Description: RESPONSIBILITIES:Kforce has a client that is seeking a Senior Engineer DevOps in Fenton, MO. You will be working closely with other engineers in an agile environment with a high degree of freedom. (more...)
Company: Kforce Technology Staffing
Location: Fenton
Posted on: 03/4/2021

Horizontal Construction Engineers (12N)
Description: Before a road, airfield, or a building can be constructed, all obstacles must be removed from the site. As a Horizontal Construction Engineer in the Army National Guard, you'll handle the heavy lifting (more...)
Company: Army National Guard
Location: Macomb
Posted on: 03/4/2021

Diesel Mechanic
Description: Great company. Great people. Great opportunities. At United Rentals, the largest equipment rental company, we believe that it takes great employees to build a great organization - and we're passionate (more...)
Company: United Rentals
Location: Roxana
Posted on: 03/4/2021

Product Configuration & Data Management Engineer
Description: Autonomous Systems, located in St. Louis, MO, has a need for an experienced Product Lifecycle Management PLM engineer who will function in a Program environment in direct support of Product Lifecycle (more...)
Company: BOEING
Location: Hazelwood
Posted on: 03/4/2021

Log In or Create An Account

Get the latest Illinois jobs by following @recnetIL on Twitter!

Decatur RSS job feeds