Belcan
Belcan provided pay range: This range is provided by Belcan. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$40.00/hr - $60.00/hr Job Title:
Sr. Validation Engineer Duration:
05 Months Contract (Potential temp to perm) Pay Rate : $40/hr. - $57/hr. for 1st shift Shift Time:
M-F, 8am-5pm Summary: 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. 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. Seek and retain approval for qualification protocols from site user groups and quality. 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: Bachelors 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 owner’s experience in manufacturing processes required. Design experience or owner’s 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
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$40.00/hr - $60.00/hr Job Title:
Sr. Validation Engineer Duration:
05 Months Contract (Potential temp to perm) Pay Rate : $40/hr. - $57/hr. for 1st shift Shift Time:
M-F, 8am-5pm Summary: 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. 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. Seek and retain approval for qualification protocols from site user groups and quality. 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: Bachelors 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 owner’s experience in manufacturing processes required. Design experience or owner’s 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
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