Atlanta New Focus Staffing Services

07/09/2022

Radio livea

06/18/2022

08/14/2020

Skills & Experience:

· Industry experience:

o Experience in manufacturing process validation required

o Experience in FDA-regulated business highly preferred

o Experience in medical Devices required

o Experience with FDA Remediation Projects/Combination Products preferred

· Hands-on experience in equipment qualification (EQ), test methods validation (TMV) and process validation (PV) required.

· Expertise in risk management and application of FMEAs to validations is required.

· Experience working with validation database applications is required.

· Strong mathematical skills and statistical analysis skills required.

· Bachelor’s degree in science or engineering required.

· Strong technical writing and analytical skills required.

· Power user of Microsoft PowerPoint, Word, and Excel.

· Takes direction well, but also takes initiative as required.

· Understands how to identify and benchmark best practices.

· Customer-focused mind-set.

· Understands how to measure and manage manufacturing costs.

· Understands how to forecast the benefits of continuous improvements.

· Preferred personality traits: intelligent, reliable, hard-working, organized, multi-tasking, results-oriented.





Job Duties:

· Perform gap analysis and remediation of legacy validations.

· Apply strong risk management techniques to statistical sampling for validations.

· Write validation plans, protocols and reports.

· Assist in executing validations.

· Mentor and coach engineering, manufacturing, quality, validation and quality personnel on the best practices for validations.

· Manage validation records in an electronic database system.

08/03/2020

JOB DESCRIPTION

ROLE SUMMARY:

This position will be responsible for performing investigational analysis and testing activities in the Product Technology Laboratory. This includes performing visual and functional evaluations, measurements, and testing as well as coordinating and overseeing testing performed by others and making sure it is executed properly. This includes creating test documentation. This is a hands-on position, and may include filling, assembly, inspection, and testing of components and auto-injectors, along with ex*****on of protocols. This person will be expected to work from detailed drawings, diagrams, protocols, verbal and written instructions. Responsibilities include analyzing findings, summarizing/ reporting data, developing inspection methods and test procedures, maintaining lab equipment, and performing mechanical engineering support work.



ROLE RESPONSIBILITIES:

· Perform investigational analysis and testing in the Product Technology Laboratory, coordinating and overseeing additional testing with others as necessary. Keep an up-to-date list of all samples received with priority, status, and due date.

· Create initial test documentation to include items such as background information, test procedures, components, equipment, and data sheets. Analyze findings, summarize, graph, and report data.

· Maintain lab equipment and a well-organized laboratory with a high focus on safety

· Work from detailed drawings, diagrams, schematics, verbal and written instructions

· Execute testing protocols as needed

· Develop inspection methods and test procedures as needed

· Attend planning meetings to provide updates as needed

· Interact with machine shops (internal or external) to fabricate testing apparatus as needed

· All other duties as assigned

QUALIFICATIONS:

· Bachelor’s degree in Engineering or Science. Related experience in a technical environment or equivalent combination of education and experience will be considered.

· 2 years’ in a pharmaceutical/ medical device laboratory with experience in measurement and inspection processes.

· Must have laboratory experience, preferably pharmaceutical.

· Potential exposure blood borne pathogens – selected candidates will need to provide proof of Hepatitis B Series vaccinations before start date.

· Laboratory experience, preferably pharmaceutical

· Experience with pharmaceutical industry, medical devices, cGMP’s

· Laboratory testing or measurements required which may include some repetitive tasks or hand movements.

· Specific vision abilities required by this job include ability to adjust focus and ability to see small solution particulate in laboratory generated samples.

· Proficient at MS Excel, Word, and knowledge of spreadsheets, graphs, conditional formatting, and formulas in MS Excel.

· Good understanding of quality principles such as sampling and defect classifications

· Very organized individual with good mechanical aptitude/ good working knowledge of mechanical devices

· Able to coordinate and work on several projects at the same time, prioritizing work load appropriately and using time efficiently. Adapts quickly to changes in priorities or assigned work.

· Able to analyze and report data. Strong mathematical and reasoning skills.

· Able to read and understand detailed drawings, diagrams, and protocols

· Self-motivated and safety-minded. Follows tasks through to completion in a timely manner with minimum supervision. Consistently produces high quality work. Able to focus on priorities and have a sense of urgency.

· Good leadership and communication skills, works well with others, good mentor to others helping out in lab

· Professional and courteous. Open to other points of view, cordial and willing to accept feedback

· Good documentation practices and legible handwriting. Able to work in a fast paced environment with good attention to detail. Right the first time approach.

· Able to easily comprehend verbal and written instructions, take good notes, and following through on actions

· Listens/ asks for clarification when needed

· Exercise sound judgment and ability to work effectively with a diverse workforce

06/18/2020

Work under the direction the Project and Validation Managers, the Senior Validation Engineer will:



Draft, lead reviews and approval of Engineering Commissioning protocols (FAT, SAT etc.) and validation protocols (IOQ and PQ protocols) to support new manufacturing line installation.
Support Execute the IOQ and PQ protocols.
Have expertise in equipment validation and Computer System Validation
Manage, track and lead closure of discrepancies and deviations of executed validation protocols
Draft and lead reviews and approval of and validation summary reports
Support vendor activities on Site during installation, commissioning, SAT and pre-IOQ protocols ex*****ons.
Support updating project ESD (Engineering Specification Document) and related SOP’s
Develop and execute validation protocols to run new autoclave cycle for new machine parts.
Participate in project team meetings.
Provide periodic progress reports and status updates to Project and Validation Managers.
Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards. Track and execute computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned.
Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).Work with the data integrity team to ensure compliance in creation and ex*****on of validation activities.
Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans,
Working knowledge of statistical analysis – Six Sigma Green Belt or equivalent.

06/11/2020

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