Job description

CSV Engineer III

Pharmaceutical Manufacturing

Irvine, CA

$115K - $125K

Overview:

The Computer Systems Validation Engineer will be responsible for overseeing new product and process validations on site.

Responsibilities:

· Ensuring the compliance of cGMP of computerised systems

· Overseeing and supporting the validation process of global systems

· The responsibility of ensuring compliance with company quality policy

· Support for the implementation and maintenance of company approved computerised systems

· Support throughout a team to achieve data integrity

Required experience and skills:

· Overseeing the computer system validation throughout the production process.

· Ensuring regulatory requirement are met throughout the validation process according to CGMP rules and FDA 21 CFR Part 11, 21, 58, 210, 211 and EU GMP Annex 11.

· Leadership skills to coordinate and collaborate in the necessary validations for computerised systems.

· The ability to assess change and approve necessary changes to computerised systems in relation to CSV.

· Document internal complaints and deviations for the computerised systems until their approval.

· Ability to verify the corrective actions agreed upon have been implemented.

· Communicate with system owners to conduct periodic CSV reviews of computerised systems.

· Assist and conduct internal and external audits.

· Maintaining CSV default documents: POs, SVs, AAs, Bes and guided templates.

· Documentation and maintenance of CSV inventories.

· Overview system documentation.

· Training and supporting colleagues regarding CSV.

· Following standard procedures in relation to CSV and company guidelines as well as the implementation of said procedures.

· Keeps up to date on company procedures, guidelines, regulatory requirements within the field of CSV.

Required qualifications and education:

· BA/BS in relevant field

· 5-7 years in the Pharmaceutical or related industry

· FDA regulatory experience

Job Type: Full-time

Salary: $115,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Signing bonus

Education:

• Bachelor's (Preferred)

Experience:

• Computer System validation: 5 years (Required)
• Pharmaceutical manufacturing: 3 years (Required)
• Regulatory Requirements: 5 years (Preferred)

Work Location: One location

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