Filter Validation Specialist
4 weeks ago
One of our large pharmaceutical clients is actively looking for a Validation Senior Specialist, specializing in Filter Validation, to join their team in West Point, PA. The Validation SME will be responsible for oversight of validation activities as part of the Bio-Sterile Validation SME Team. Main responsibilities include
change control assessments
for filters, leachable & extractables, & supporting Integrated Product Teams (IPTs) involved in vaccine manufacturing.
The Senior Specialist SME will review and approve
validation documentation
(including but not limited to; validation strategies, detail design, user requirements document) related to new or existing manufacturing sterile projects to ensure successful completion is in alignment with validation requirements.
Validation disciplines can range, but are not limited to
Container Closure Integrity, Filter Assessments, Extractables and Leachables, Cleaning, Sterilization, or Controlled Temperature Units.
Also, when required the Sr. Specialist SME will be required to train and coach junior engineer/specialist in the area of Validation.
Required Skills and Experience
BS, Engineering or Sciences
7+ years' experience in Validation
Expertise in Filter Validation
Extractables & Leachables
Equipment Sterilization Experience
GMP Pharma Regulated Environment Experience
Strong knowledge and hands on experience interpreting guidance/guidelines such as but not limited to; Annex 1, ISO, USP, PDA and AAMI for different leachable/extractable testing and Filter validation.
Nice to Have Skills and Experience
Audit Experience
Equipment Manufacturing
Gamma Sterilization
Experience using KNEAT/eVal
This is a year extending contract, working 4 days onsite, 1 day REMOTE
Compensation :
$70/hr to $85/hr.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
-
Validation Specialist I
4 weeks ago
New York, United States CareerBuilder Full timeDescription We're looking for a Validation Specialist I , working in Pharmaceuticals and Medical Products industry in 55 Corporate Drive, Bridgewater, New Jersey, 08807, United States . Job description: Manages system documentation review, storage, versioning and signature collection. Interacts with end users to gather business requirements and information...
-
Computer System Validation Specialist
6 days ago
New York, United States Ask Staffing Full timeJob Title: Computer System Validation Specialist Duration: 11 Months Pay: $53- $55.57 Location: Syracuse NY This is not a remote position. We require MINIMUM on site in Syracuse 50%. Qualifications: ÂÂÂÂÂ Experience in Computer System Validation ÂÂÂÂÂ Able to develop documentation required for a 21 CFR Part 11 validated project, including...
-
Amazon Ads PPC Specialist
1 month ago
New York, United States Custom Filters Direct Full timeCompany DescriptionCustom Filters Direct is a leading supplier of custom odd size HVAC filters for commercial and residential buildings. We serve thousands of customers and offer flexible order options. Whether you need a case of custom filters or a truckload, our team is dedicated to providing exceptional service.Role DescriptionThis is a full-time remote...
-
Amazon Ads PPC Specialist
4 weeks ago
New York, United States Custom Filters Direct Full timeCompany DescriptionCustom Filters Direct is a leading supplier of custom odd size HVAC filters for commercial and residential buildings. We serve thousands of customers and offer flexible order options. Whether you need a case of custom filters or a truckload, our team is dedicated to providing exceptional service.Role DescriptionThis is a full-time remote...
-
Quality Validation Engineering Consultant
18 hours ago
New York, United States cyberThink Full timeJob Description: This position of Validation Specialist is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the industrial sites. The mission is to deliver robust and efficient process &...
-
Equipment Validation Specialist
2 weeks ago
New York, United States Portal Insulin LLC Full timeCompany Background Portal Insulin LLC (Portal) is a pre-clinical company developing an insulin formulation for use in treating diabetes mellitus. Portal’s primary mission is to provide a stable insulin product for use in implantable pumps. Objectives The successful candidate will be responsible for ensuring all equipment used in operations to run tests and...
-
Quality Engineer
20 hours ago
New York, United States INTELLECTT INC Full timeTitle: Quality/Test Engineer 4 Location: Mossville, IL HYBRID Job Description: Position’s Contributions to Work Group: - A test engineer that will do some component validation, tool design, actual bench testing, presenting to peers, design collaborations, working with suppliers, performing process change notifications and validations, bench design,...
-
Claims Specialist
2 weeks ago
New York, United States LHH Full timeLHH Recruitment Solutions is seeking a Claims Specialist for a great plaintiff law firm. This opportunity is full time and hybrid out of New York, NY. Hours: 9:30am - 5:30pm, overtime when necessary Responsibilities Format documents and communications for clients; review documents (release/document verification) for production to defense counsel for...
-
Claims Specialist
1 week ago
New York, United States LHH Full timeLHH Recruitment Solutions is seeking a Claims Specialist for a great plaintiff law firm. This opportunity is full time and hybrid out of New York, NY. Hours: 9:30am - 5:30pm, overtime when necessaryResponsibilitiesFormat documents and communications for clients; review documents (release/document verification) for production to defense counsel for quality...
-
Claims Specialist
3 weeks ago
New York, United States LHH Full timeLHH Recruitment Solutions is seeking a Claims Specialist for a great plaintiff law firm. This opportunity is full time and hybrid out of New York, NY. Hours: 9:30am - 5:30pm, overtime when necessaryResponsibilitiesFormat documents and communications for clients; review documents (release/document verification) for production to defense counsel for quality...
-
Claims Specialist
3 weeks ago
New York, United States LHH Full timeLHH Recruitment Solutions is seeking a Claims Specialist for a great plaintiff law firm. This opportunity is full time and hybrid out of New York, NY. Hours: 9:30am - 5:30pm, overtime when necessaryResponsibilitiesFormat documents and communications for clients; review documents (release/document verification) for production to defense counsel for quality...
-
OFAC Consultant Temp
1 month ago
New York, United States ACG Resources Full timeJob DescriptionJob DescriptionOFAC Consultant Temp Located Onsite in Manhattan with a foreign bank Job Requirements: Bachelor's degree or above; 1-3 years’ experience in financial institutions; Specific knowledge required: Strong sanctions knowledge, knowledge of business writing; Specific skills required: Strong documentation skills, technical...
-
Color Print Specialist
2 weeks ago
New York, United States Advantage Reprographics Full timeJob DescriptionJob DescriptionAdvantage Reprographics is looking for an experienced Color Print Specialist to join our team. Pay is competitive and will depend on your experience and discussed during the interview.Color Print Specialist Responsibilities:Receive, process, and maintain orders for wide format printers to perform color print services and...
-
Assessment Specialist
10 hours ago
New York, New York, United States The Port Authority of NY & NJ Full timeThe Human Resources Department is seeking an Assessment Specialist in the Assessment Services Unit. The Assessment Specialist will work as part of a team that is responsible for developing valid selection processes that ensure the highest quality of candidates for a wide range of Port Authority positions. The Assessment Specialist will be primarily focused...
-
Fircosoft Application Specialist
1 day ago
New York, United States New York Technology Partners Full timeJob Summary:The Fircosoft Application Specialist supports the Fircosoft Sanctions screening systems and services within the Compliance Technology division. The Sanctions screening system ensures that SMBC meets all its risk, legal, and regulatory responsibilities related to Sanctions Screening, Know Your Customer (KYC), and Anti-Money Laundering (AML). The...
-
Fircosoft Application Specialist
1 day ago
New York, United States New York Technology Partners Full timeJob Summary:The Fircosoft Application Specialist supports the Fircosoft Sanctions screening systems and services within the Compliance Technology division. The Sanctions screening system ensures that SMBC meets all its risk, legal, and regulatory responsibilities related to Sanctions Screening, Know Your Customer (KYC), and Anti-Money Laundering (AML). The...
-
Fircosoft Application Specialist
2 days ago
New York, United States New York Technology Partners Full timeJob Summary:The Fircosoft Application Specialist supports the Fircosoft Sanctions screening systems and services within the Compliance Technology division. The Sanctions screening system ensures that SMBC meets all its risk, legal, and regulatory responsibilities related to Sanctions Screening, Know Your Customer (KYC), and Anti-Money Laundering (AML). The...
-
Janitorial Specialist
3 weeks ago
New York, United States Bestselfwny Full time**Janitorial Specialist** **Job Title:** Janitorial Specialist **Reports To**: Janitorial Supervisor **FLSA Status:** Non-Exempt **Notice:** 2 Weeks **Grade:** 1 **SUMMARY OF DUTIES:** The position is responsible for janitorial duties performed according to established routines and procedures and is repetitive in nature. Work may require lifting of heavy...
-
Outreach Specialist
1 month ago
New York, United States Volunteers of America - Greater New York, Inc. Full timeVolunteers of America-Greater New York (VOA-Greater New York) is an anti-poverty organization working to end homelessness in the New York area by 2050. We operate over 60 programs across New York City, Northern New Jersey and Westchester County including emergency, transitional and permanent housing. Our services extend to families experiencing homelessness,...
-
Shipping Specialist
3 days ago
New York, United States PersonalRX Full timeJob DescriptionJob DescriptionThe Shipping Specialist is responsible for:Daily Tracking shipping supplies (e.g., boxes, cold packs, plastic bags, white bags, etc) and contacting the PersonalRx Purchasing agent when supplies are lowComplete packing and shipping of each patient order (SOP 3.6)Complete order consolidation Retrieve refrigerated product from...