inSync Staffing
Get AI-powered advice on this job and more exclusive features. This range is provided by inSync Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $55.00/hr - $80.00/hr
Direct message the job poster from inSync Staffing
Overview 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.
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 ensure 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 of 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
Experience with writing validation protocols and design validation studies and executing protocols/studies, analyzing data and writing validation reports
MUST BE OPEN TO WORKING SOME WEEKENDS AND OT due to project schedules and equipment installations
Benefits
Health insurance
Health savings account
Vision insurance
Flexible spending accounts
Life insurance
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at inSync Staffing by 2x
Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Get notified about new Validation Engineer jobs in
San Diego, CA .
San Diego, CA $70,000.00-$80,000.00 1 year ago
Poway, CA $80,000.00-$105,000.00 1 month ago
Poway, CA $80,000.00-$120,000.00 1 month ago
Poway, CA $98,100.00-$171,398.00 21 hours ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Base pay range $55.00/hr - $80.00/hr
Direct message the job poster from inSync Staffing
Overview 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.
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 ensure 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 of 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
Experience with writing validation protocols and design validation studies and executing protocols/studies, analyzing data and writing validation reports
MUST BE OPEN TO WORKING SOME WEEKENDS AND OT due to project schedules and equipment installations
Benefits
Health insurance
Health savings account
Vision insurance
Flexible spending accounts
Life insurance
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at inSync Staffing by 2x
Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Get notified about new Validation Engineer jobs in
San Diego, CA .
San Diego, CA $70,000.00-$80,000.00 1 year ago
Poway, CA $80,000.00-$105,000.00 1 month ago
Poway, CA $80,000.00-$120,000.00 1 month ago
Poway, CA $98,100.00-$171,398.00 21 hours ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr