Validation Technician 1
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MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
PURPOSE OF THE POSITION
Perform entry level validation tasks. Responsible for executing validation protocols, writing final reports and ensuring that all validation related activities and documentation are on file and representative of cGMP requirements for a contract manufacturing facility. The Validation Technician reports to the Engineering Department Manager and assists in meeting the corporate production and growth goals, working with a senior level Validation Specialist. In meeting these goals, the Validation Technician will ensure that validation is performed on schedule in a prompt and efficient manner.
PRIMARY ESSENTIAL JOB FUNCTIONS
* Perform Protocol Executions generated by a senior level Validation Specialist
* Write Final Reports
* Assist in the review and update of System and Equipment related SOPs
* Facilitate the routing and approval of protocols and SOPs
* Document deviations, system failures, investigations, and corrective actions
* Personal development in the generation of system, equipment and process related validation protocols (IQ, OQ and PQ)
DEPARTMENTAL JOB FUNCTIONS
* Perform operational monitoring of all facility systems and equipment as part of Engineering Department Requirements
* Complete daily facility inspection checklists
* Participate in the On-Call rotation for after-hours response
* Assist with troubleshooting of equipment malfunctions as needed
* Escort contractors and vendors during performance of troubleshooting, testing and Engineering related activities
* Assist in the performance of Calibration related activities as needed
* Assist in the performance of Preventive Maintenance (PM) activities as needed
* Provide technical support to all departments in a quality and service oriented approach
* Respond to Service Requests for troubleshooting and repair of facilities and equipment
* Maintain job related GMP training and qualifications in accordance with SOPs
* Maintain requirements to work in clean rooms
* Document PM, Calibration and Service Request activities in accordance with SOPs
Bachelors degree in science
2 years of Technical, Vocational training, i.e., Mechanical, Electrical, Control Systems
Specialized military training, i.e., Nuclear Power or equivalent experience
2 years of experience in a regulated environment preferred
Essential and Critical Skills:
* Excellent written and verbal communication skills
* Excellent computer skills, Microsoft Word and Excel
* Good organizational skills
ADDITIONAL LOCAL NEEDS
The employee must have the local ability to respond on site to address emergency alarm notifications within 30 minutes.
The employee must have reliable means of transportation to and from the facilities for On-Call duties.
The employee must be able to work off-shifts, weekends, and additional hours as required.
The employee must have the ability to perform moderately physical activity.
The employee must have the ability to perform very complex tasks with attention to detail.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is rarely exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.