Jobs in the United States

25+ jobs

Save this search

Added just now
Sr Fiber Deploy TIPM, Global Connectivity Infrastructure Development
Amazon
Denver, CO
Amazon Web Services is looking for a Sr. Technical Infrastructure Program Manager (Sr. TIPM) to support and deploy one of the world’s largest and most complex telecommunication networks.…
Added 1 min ago
Senior Manufacturing Engineer
IDEX
Denver, CO
Drive innovation and efficiency by leading advanced design projects, commissioning new equipment, and optimizing existing processes. Collaborate with cross-functional teams to deliver…
Added 1 min ago
Principal Aftermarket Technical Product Manager
GE Aerospace
Lafayette, CO · Denver, CO · Longmont, CO
Compliance by design ** Ensure solutions meet Aerospace quality, regulatory and compliance requirements, including traceability, airworthiness release documentation, export control,…
Added 3 mins ago
Engineering Manager
Morton Salt
Silver Springs, NY
Morton Salt Silver Springs, NY has an immediate opening for an Engineering Manager. The manager would be responsible for the safe and efficient operation of the Engineering Department at…
Added 7 mins ago
F135 PP&S Sustainment Manager
RTX
United States
Pratt & Whitney’s Program Planning & Scheduling (PP&S) organization is searching for a manager, supporting F135 Sustainment. The PP&S organization works with key program stakeholders to…
Added 14 mins ago
G
Fire Sprinkler Design Manager
GPAC
Austin, TX
- $35 to $40 USD / hour
We are seeking a skilled Fire Sprinkler Design Manager/Lead to join the team. The ideal candidate will have at least 5+ years of experience in fire sprinkler design, preferably with NICET…
Added 18 mins ago
G
Senior Mechanical Project Manager
GPAC
Spring, TX
- $120,000 to $160,000 USD / year
The Senior Mechanical Project Manager is responsible for leading complex mechanical construction projects from preconstruction through closeout. This role requires exceptional leadership,…
Added 25 mins ago
G
Civil Engineer (PE or EIT)
GPAC
Nashville, TN
- $100,000 to $150,000 USD / year
Ensure quality control and adherence to regulatory standards
Added 26 mins ago
G
Civil Engineer (PE or EIT)
GPAC
Tucson, AZ
- $100,000 to $150,000 USD / year
Ensure quality control and adherence to regulatory standards
Added 27 mins ago
AS
Project Manager - Federal Construction
Aerostar SES LLC
Seattle, WA
- $125,000 USD / year
…safety and occupational health management, and assurance of quality and compliance. Responsible for overseeing a variety of construction projects, including design-build and bid-build…
Added 50 mins ago
G
Manufacturing Engineering Manager
GPAC
Nashville, TN
- $105,000 to $158,000 USD / year
Quality: • Ensure standardized work, CTQs, and process control plans are developed, implemented, and maintained. • Define and document standard ME processes to ensure engineering projects…
Added 51 mins ago
G
HVAC & Mechanical Project Manager
GPAC
Iowa City, IA
- $90,000 to $130,000 USD / year
The HVAC & Mechanical Project Manager is responsible for planning, coordinating, and executing commercial and/or industrial HVAC and mechanical construction projects from kickoff through…
Added 51 mins ago
G
HVAC & Mechanical Project Manager
GPAC
Davenport, IA
- $90,000 to $130,000 USD / year
The HVAC & Mechanical Project Manager is responsible for planning, coordinating, and executing commercial and/or industrial HVAC and mechanical construction projects from kickoff through…
Added 51 mins ago
G
Manufacturing Engineering Manager
GPAC
Clarksville, TN
- $105,000 to $158,000 USD / year
Quality: • Ensure standardized work, CTQs, and process control plans are developed, implemented, and maintained. • Define and document standard ME processes to ensure engineering projects…
Added 52 mins ago
Sector Lead - Transportation Infrastructure Engineering - Tennessee
Atlas
TN · Bartlett, TN · Chattanooga, TN · Knoxville, TN · Memphis, TN · Murfreesboro, TN · Jackson, TN · Nashville, TN
Oversees daily activities, solving problems as needed, and monitoring quality control activities of the sector.
Added 52 mins ago
A
Environmental Civil Site Engineer, Land Development
Atlas
Pittsburgh, PA · PA
- $95,000 to $110,000 USD / year
…grading, hydrology and hydraulics (H&H), and stormwater management design under the direction of a Project Manager or Senior Engineer. Work includes developing civil design drawings and…
Added 52 mins ago
Sr Highway Design Engineer/Project Manager
Atlas
Duluth, GA
We are seeking a Sr Highway Design Engineer/Project Manager (Roadway Engineer 3) to join our Georgia team! Come join us!
Added 52 mins ago
A
Senior Transportation Project Manager (Roadway Design & Client Development)
Atlas
Chicago, IL
- $275,000 USD / year
Atlas is seeking an experienced Senior Transportation Project Manager (Roadway Design & Client Development) to lead high-profile roadway and transportation infrastructure projects…
Added 52 mins ago
Water Compliance Consultant (MS4)
Atlas
East Hartford, CT · CT · ME · NH · VT · MA · RI
…both public and private clients. Our services help improve the quality of life in the communities where we live and work. We always aim for smart, safe, and sustainable results. At Atlas we…
Added 52 mins ago
A
Sr Environmental Compliance Manager
Atlas
Redmond, WA · Seattle, WA
- $140,000 to $160,000 USD / year
We are seeking a Senior Environmental Compliance Manager to join our Redmond, WA team! Come join us! The Senior Construction Environmental Compliance Manager leads and delivers…
Added 52 mins ago
A
Environmental Compliance Manager
Atlas
Redmond, WA · Seattle, WA
- $100,000 to $115,000 USD / year
We are seeking an Environmental Compliance Manager to join our Redmond, WA team! Come join us! The successful construction Environmental Compliance Manager supports and delivers…
Added 53 mins ago
G
HVAC & Mechanical Project Manager
GPAC
Tennessee
- $90,000 to $130,000 USD / year
The HVAC & Mechanical Project Manager is responsible for planning, coordinating, and executing commercial and/or industrial HVAC and mechanical construction projects from kickoff through…
Added 53 mins ago
G
HVAC & Mechanical Project Manager
GPAC
Minneapolis, MN
- $90,000 to $130,000 USD / year
The HVAC & Mechanical Project Manager is responsible for planning, coordinating, and executing commercial and/or industrial HVAC and mechanical construction projects from kickoff through…
Added 53 mins ago
G
HVAC & Mechanical Project Manager
GPAC
Missouri
- $90,000 to $130,000 USD / year
The HVAC & Mechanical Project Manager is responsible for planning, coordinating, and executing commercial and/or industrial HVAC and mechanical construction projects from kickoff through…
Added 1 hour ago
Traveling Superintendent - Mission Critical / Data Center / Healthcare
GPAC
Columbus, OH
…mobilization through closeout and work closely with the Project Manager. Expect extensive travel. Midwest or Southeast based candidates…

Validation & Engineering Group

Sr Quality Assurance (Validation) Engineer - FL, USA

Deerfield Beach, FL, United States

Apply About employer

Applications open in a new tab.

Job details

Experience: · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance.
Posting language: English
Posted: Apr 16, 2021

Original job description

Company Description Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

Reporting to the Senior Quality Assurance Manager, this position is responsible for Quality oversight of the local validation program which includes Facilities, Utilities, Manufacturing equipment and Computer Systems. The Engineer will contribute improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of Operations, Process Development, and IT. The engineer will approve validation, change control, investigation of events as well as provide Quality oversight and/or Quality approvals for GxP systems. The CSQA Engineer will provide oversight of SHL Pharma GxP related applications, and established Quality Operating procedures. In addition; will maintain a list of all computerized systems that are used in support of manufacturing operations, assure 21 CFR Part 11 pre- and post-assessments are performed on all systems and that computerized systems are released to production in accordance with local and global policies and procedures. The CSQA Engineer will review and approve validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts and discrepancies. In addition, will provide guidance to project teams on the deliverables required as part of the validation package. Assure that computerized systems are in the requalification program and are part of the program for security access roster review. · To Implement and maintain global and local procedures for computerized systems validation. · To drive standardization and continuous improvement activities across the global and local quality network · To provide QA oversight, review and approval of the activities related to the design, test, implementation, and maintenance of supported GxP systems.

· To help plan audit program and execute audits of:

Suppliers of computerized systems, components, and services
Computerized systems, projects and processes related to Computerized system.
Computerized systems at SHL’s partners (e.g. CMO Customers}, upon request · To monitor Quality Metrics and communicate to management to drive continuous improvement of regulated computerized systems and GXP relevant infrastructure. · To Identify and communicate risk in area of responsibility and across the quality network; creating strategies and plans to manage the risk. · To ensure deviations from established procedures are documented per procedures. · To ensure that all changes that potentially impact product quality are documented per procedure. · To ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Advises site management regarding Quality Assurance issues

Qualifications

· Bachelor’s degree in Computer Science / Computer or Biomedical Engineering · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance. · Demonstrated knowledge of predicate rules such as GLP, GMP, GCP, GAMP 5 as they relate to computerized systems. · Must have a strong knowledge and application of the CFR’s and cGMP’s. · Comprehensive knowledge of FDA, EMA, JP, ISO and other regulations and experience in US and international regulatory agency inspections. · Knowledge of regulations and practices pertaining to pharmaceutical/medical devices products in your area of responsibility. · Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. · Excellent oral and written communication skills with strong technical writing experience required. · Experience in internal / external audits, identify findings, drive resolution and provide closure report. · Proficient skills in solving complex problems and ability to bring issues to resolution. · Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. · Must be able to successfully pass a pre-employment drug test and background check. Experience working globally with diverse teams and cultures

Additional Information All your information will be kept confidential according to EEO guidelines.

Apply About employer

Report this job