Website Kaztronix
Kaztronix
Company : Kaztronix
The Validation Engineer is responsible for the execution and management of qualification/validation activities for process, cleaning, equipment, computer software or facilities on site. The engineer prepares and executes validation/qualification and re-qualification activities as necessary for new and modified process, cleaning, equipment, computer software or facilities so that the qualification status is maintained at all times. The engineer also assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources. This is a fast-paced environment with changing deadlines and priorities and will involve lots of multi-tasking and flexibility to adjust to these changes.
Primary Job Responsibilities :
Ensure all company and Site Validation policies and procedures are adhered to.
Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.
Ensure all work undertaken is reflected accurately in up to date Validation / project information files.
Lead/support the development of process, cleaning, equipment, computer software or facilities qualification protocols and ensures they are in line with Validation policies and guidance documents (Liaising with equipment manufacturers, internal and external project personnel to ensure successful qualification execution).
Seek and retain approval for qualification protocols from site
User groups (who approve documents from a user group operations perspective)
Quality (who approve documents from a regulatory compliance standpoint)
Lead the execution of qualification protocols on process, cleaning, equipment, computer software or facilities as necessary.
Ensure the maintenance of a qualification/validation document listing for all qualified/validated process, cleaning, equipment, computer software or facilities on site.
Ensure all qualification documentation is maintained up to date at all times.
Provide expert guidance for the resolution of technical issues arising during the execution of qualification activities.
Perform any other activities as directed by the Validation Manager.
Position will involve 50/50 on process and equipment validation
Education & Experience Required:
" Bachelor s in Mechanical or Chemical Engineering, Science, or related field.
" at least 5-7 years experience in pharmaceutical/biotech operations
" Minimum 5 years direct/ hands on experience with validation of process, cleaning, equipment, computer software or facilities with thorough working knowledge production unit operations and validation principles.
Knowledge, Skills & Abilities:
" Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required.
" Technical expertise in biotech unit operations, ability to handle multiple projects at one time.
" Design experience or owners experience in manufacturing processes required.
" Design experience or owners experience in utility systems including purified water, WFI, CIP, SIP, compressed air and waste treatment desired.
" Working knowledge of processes in fermentation, purification and/or formulation required.
" Strong leadership, organizational planning, and project management skills
" Excellent interpersonal effectiveness and communication skills (written and oral)
" Ability to work with a cross functional team to achieve expected results
" Proficient in MS Word, Excel, and Project
" Good writing and communication skills, team player
" Experience with design transfer
" Should have experience with writing validation protocols and design validation studies and executing protocols / studies, analyzing data and writing validation reports
This facility is a smaller production scale facility for testing reagents and the facility is expanding their fill lines and there will also be validation of processes and some custom equipment at the manufacturing and lab scale. The team consists of 5 engineers with one principal engineer on a campus with 3 buildings. The person in this role will need to be flexible and able to follow the validation processes and not want to reinvent the wheel or bring in past processes that conflict with current processes. Deadlines are changing and it is a fast-paced environment with lots of changing priorities able to multi-task.
MUST BE OPEN TO WORKING SOME WEEKENDS AND OT due to project schedules and equipment installations