Posted on
Validation Specialist IQ, OQ, PQ cell therapy Allendale, NJ ref
Skills: IQ, OQ, PQ, basic cell processing, QC lab equipment, Validation experience, Kaye Validator, Tachometer, Multimeter, 21 CFR, Part 11
Experience level: Associate Experience required: 5 Years Education level: Bachelor’s degree Job function: Research Industry: Biotechnology Compensation: View salary Total position: 1 Relocation assistance: No Visa : Only US citizens and Greencard holders
Validation Specialist
The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Essential Functions and Responsibilities
Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc.
Execute IQ/OQ and /or PQ protocols.
Prepare final reports for executed protocols
Prepare final reports for vendor IQ, OQ and/or PQ protocols.
Review of executed IQ/OQ/PQ protocols and raw data.
Perform periodic review/requalification of validated equipment, systems and cleanrooms
Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met.
Qualifications
Minimum BS/BA in engineering or a related Science discipline and 3-7 years of validation experience.
Good computer skills and Microsoft Office knowledge.
Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc.
Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11.
CDMO experience
Competencies/Candidate Profile
Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary.
Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management.
Must be a dedicated self-starter with a high energy level and able to achieve results.
Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution.
Good time management skills to manage and meet deadlines.
Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment.
Ability to multi-task team is essential.
Flexible and able to adapt to company growth and evolving responsibilities.
Highly organized, detail oriented, and ability to manage multiple priorities.
Supervisory Responsibility
Ability to perform the job under direct or indirect supervision
Working Environment
May occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.
Must have the ability to work in a team-oriented environment and with clients
Must have the ability to work with specialized equipment
This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
Ability to work in cleanroom environment for a moderate amount of time.
Ability to lift, transfer, or ship validation equipment or related accessories.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. The employee is occasionally required to lift and/or move up to 30 pounds.
Must where PPE when appropriate.
jonathan AT executivestaffrecruiters DOT com
Please take the time to accurately and completely fill out this form by answering each specific
question. Not only will we refer to it regularly, but this information may also very well be shared Gift 101with clients
interested in interviewing you. The better we know what you want the better positions you will
see.
Name:
Please give us the best email and phone number to contact you.
1. What is motivating your decision to leave your current job?
2. Describe your search activity over the past 3 to 6 months. Are you selectively searching or
actively looking at this moment?
3. Do you have the appropriate citizenship or visa to work in the US without restriction or time limit?
4. Describe in detail what you would be doing in your ideal next position. Who would you report to, who
would report to you, what types of projects would you be working on? The more detail you provide
the better for us to understand your career aspirations.
5. Where in your area are you willing to work? How far are you willing to travel to and from
work? Are you willing to relocate? If yes, to what area? If relocation is of interest, what
hurdles will you have to overcome before starting a new position?
6. What type of relocation package do you require?
7. What is your availability?
8. Do you have a non-compete or a reimbursement clause?
9. What are you looking for in compensation? Please remember that it is my job to get you the
best salary possible from the client. So please complete this area and be honest in the salary
you are looking for now. I do not discuss this with my client.
Base Salary
Target Bonus %
Average Bonus (past 3 yrs.)
Vacation
All Other CompensationBy
10. What are your thoughts concerning your susceptibility to a counteroffer from your current
employer? Have you ever been given a counter offer? Did you accept it or turn it down?
Why?
11. Why are you interested in this opportunity?
12. Promise to stay in touch via email?
Summary:
Selling points:
Red Flags
Best Phone Number:
Best Email address:
Best time to contact:
Current Compensation:
Targeted Compensation: market /
Work Authorization: US
Location/Commute/Relocation:
Enjoy your day!