Advanced Clinical
Overview
We are currently searching for a skilled professional to join a well-known client’s team as a Validation Engineer in San Diego, CA. 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. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
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
Experience
Minimum of 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.
Education
Bachelor’s in Mechanical or Chemical Engineering, Science, or related field.
To Be a Best-fit Your Strengths Must Include
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
About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Referrals increase your chances of interviewing at Advanced Clinical by 2x
Get notified about new Senior Validation Engineer jobs in
San Diego, CA .
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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
Experience
Minimum of 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.
Education
Bachelor’s in Mechanical or Chemical Engineering, Science, or related field.
To Be a Best-fit Your Strengths Must Include
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
About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Referrals increase your chances of interviewing at Advanced Clinical by 2x
Get notified about new Senior Validation Engineer jobs in
San Diego, CA .
#J-18808-Ljbffr