Sr. CSV Engineer

Apex Systems is seeking a Senior Software/CSV Engineer to join our client, a global leader in the medical device industry. This will be starting as a 6-month contract, with potential to extend or convert after that duration. It will be onsite in Jacksonville, FL.

The Senior Software/CSV Engineer will lead software validation activities and projects with a specific focus on manufacturing systems. Create, review, and approve software validation documentation and change requests. Execute and document qualification protocols and reports. Review and approve software test cases

Essential duties

- Assess and lead the CSV package(s) on an assigned project.

- Taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position.

- Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, Validation Reports.

- Perform CSV periodic review of equipment and systems.

- Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)

- Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards

- Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners

- Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups

- Coordination and oversight of external subcontractors / software suppliers when required

- Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV

- Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems are assessed and resolved.

Requirements:

- Bachelor/Master's degree in related discipline

- Ability to work in a fast-changing environment

- A minimum of 4 years of working experience within med device/ pharma/biotech industry

- Experience on validating computerized manufacturing equipment (CSV context)

- Experience on validating software & hardware infrastructure (e-g: servers, network and software services).

- A minimum of 4 years of working experience with CSV

- Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines

- Excellent communication skills

- Analytical thinking and problem-solving ability

- Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast-paced environment

- Experience on validating complex computerized analytical equipment (QC Laboratory equipment)

- Basic know-how of Validation requirements according to cGMP regulations

- Basic know-how of quality assurance principles

Required Skills : -Software Validation -Test plans/procedures -Machine Vision experience -Medical Device/Pharma experience

Basic Qualification :

Additional Skills :

Background Check :Yes

Drug Screen :Yes

Notes :

Selling points for candidate :

Project Verification Info :

Candidate must be your W2 Employee :Yes

Exclusive to Apex :Yes

Face to face interview required :No

Candidate must be local :Yes

Candidate must be authorized to work without sponsorship ::No

Interview times set :Yes

Type of project :Development/Engineering

Master Job Title :Eng: Quality Engineer

Branch Code :Jacksonville