Are you interested in working at an innovative Medical Device/Pharmaceuticals company?

Job Responsibilities:

• Serves as validation representative for laboratory instruments and partners with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site.
• Initiates and leads risk assessment, gap analysis and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Laboratories.
• Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.
• Ensures lab instrument’s adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies with core stake holders to mitigate the gaps.
• Assists the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans.
• Previous experience with Trackwise PR/CAPA systems preferred.
• Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
• All other duties as assigned.

Required Skills:

1. Validation of laboratory instruments including those with computer system attached for instrument control (i.e. AA, FT-IR, ICP-MS, TOC, UV_Vis)

2. Experience with configuring, testing and validating the laboratory systems to demonstrate compliance with 21 CFR Part 11/Annex 11 as well as proposing procedural controls if the system is unable to fully meet the requirements

3. Hands on experience operating the instrument systems to be able to write test scripts to demonstrate the essence of the Part 11 regulations which is to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. As such the electronic records should not be susceptible to unauthorized access, alteration/modification, deletion, or other methods of falsification and the audit trail must capture changes. These records need to be accurate and be accessible/available for the duration of data retention period in case it is needed for regulatory or other audits.

4. Must be able to multi-task – new/multiple projects will be thrown at the worker constantly, must be able to handle all of them.

5. Detail oriented is a must.

Experience:

• 3-5 years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment
• Hands on experience validating various laboratory instrument systems (e.g. PerkinElmer AA, FT-IR, Climet CI-150t, IC, Agilent ICP-MS, Instron 5965, Keyence IM-7030, SmartScope Flash 500, TOC, UV_Vis)
• Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the system’s data integrity and FDA 21 CFR Part 11 controls.

Minimum Qualifications:

• Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
• Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes.
• 5+ years exp.
• Ability to manage multiple activities and constantly change priorities.
• Exposure to lab operations and scientific processes associated as well as familiarity with a variety of laboratory instruments with various areas (Chemistry, Micro, Biological, EM etc.)
• Strong critical thinking and problem solving skills.

Location: Rocky Mount – NC

Employment Type: W2 employee with competitive benefits.

Benefits:

• Choice of medical, dental, and vision plans.
• Paid vacation time.
• Competitive hourly rate.

This is a great opportunity and we're looking to fill this role with the right person. If you are ready to embark on an amazing new career opportunity, APPLY RIGHT NOW!

About Ventura Solutions:

Ventura Solutions is a rapidly growing medical device and pharmaceutical staffing, consulting, and training firm. Our extensive industry expertise in medical device, pharmaceutical, and combination products along with an exceptional talent pipeline make us a top choice for a wide range of projects. We also offer great benefits which enable us to attract and retain top talent in the medical device, pharmaceutical, and combination products space. For more information and other job opportunities visit us at ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled