Jobs in the United States

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Added 34 mins ago
Senior Specialist - Biologics Pilot Plant Automation Engineer (On-site)
Merck
West Point, PA · Rahway, NJ · Durham, NC · North Wales, PA · Upper Gwynedd, PA
We are seeking a Senior Specialist, Pilot Plant Automation Engineer to join the Research & Development Division Biologics Pilot Plant Automation Engineering Group. This individual will lead…
Added 38 mins ago
Sr Mgr, Supplier Quality Management
x Varian Medical Systems, Inc.
United States
…controls, and the effective application of APQP, PPAP, SPC, process capability, FMEA, Lean, Six Sigma, and other preventive quality…
Added 1 hour ago
Sr. Reliability Engineer
CSL Behring L.L.C.
United States
…operations by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause…
Added 1 hour ago
Process Engineer II/III - API (Recovery) Mon-Fri shift
Novo Nordisk
Clayton, NC
Support operations within the area through process knowledge sharing, critical decision making and strategy
Added 1 hour ago
Process Engineer II/III - API (Recovery) Mon-Fri shift
Clayton
Support operations within the area through process knowledge sharing, critical decision making and strategy
Added 1 hour ago
3K
Engineer – GMP Drug Product Manufacturing Equipment & Reliability - (JP16085)
3 Key Consulting
Thousand Oaks, CA
- $41 to $46 USD / hour
Job Title: Engineer – GMP Drug Product Manufacturing Equipment & Reliability - (JP16085)
Added 1 hour ago
3K
Engineer – GMP Drug Product Manufacturing Equipment & Reliability (JP16083)
3 Key Consulting
Thousand Oaks, CA
- $41 to $46 USD / hour
Job Title: Engineer – GMP Drug Product Manufacturing Equipment & Reliability (JP16083)
Added 1 hour ago
M
Associate Process Engineer
MILLIPORESIGMA
SHEBOYGAN FALLS, WI
- $33 to $51 USD / hour
Added 3 hours ago
QA Engineer, Drug Product - Second Shift
Fujifilm
Holly Springs, NC
The QA Operations Engineer is responsible to help drive the Quality oversight for Drug Product Manufacturing area and processes during second shift. This role collaborates within the DP…
Added 3 hours ago
MES Engineer IT Systems
JuN - Seattle Dexter
Bothell, WA
…supporting the Breyanzi (CAR T cell therapy) manufacturing process at BMS, Bothell. This individual serves as the process and product expert who translates Manufacturing, Quality and Supply…
Added 4 hours ago
HI
Senior Principal Engineer, Spray Drying Process Development
Halozyme, Inc.
United States
- $215,000 to $240,000 USD / year
The Senior Principal Engineer, Spray Drying Process Development, will lead the development, characterization, scale-up, and technology transfer of spray-drying processes for biotherapeutic…
Added 4 hours ago
Sr. Quality Assurance Engineer
Nextern
Maple Grove, MN
Review batch records and travelers for GMP compliance.
Added 4 hours ago
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Sr. Engineer, MS&T – Aseptic Drug Product
(FCRS = US473) Novartis Innovative Technologies Inc
United States
- $114,100 to $211,900 USD / year
Imagine being at the forefront of delivering life-changing sterile medicines to patients around the world. As Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, you…
Added 4 hours ago
Maintenance Supervisor
The Cheesecake Factory
Battleboro, NC
Enforce maintenance standard work, safety practices, and GMP compliance.
Added 5 hours ago
EC
Packing Operator
Evonik Corporation_4142
Chester, PA
- $28.57 USD / hour
Our success hinges on a diversity of ideas powered by people, not egos. Whether you’re a scientist or engineer, new to the team or established, in business, production, or anything in…
Added 5 hours ago
Project Engineer
Ya Ya Foods USA LLC
Ogden, UT
Maintain strict GMP (Good Manufacturing Practices).
Added 5 hours ago
Staff Packaging Engineer
BeOne Medicines US Manufacturing Co., Inc.
United States
As part of the Manufacturing Science and Technology group, the Staff Packaging Engineer will provide life cycle validation technical support for the Oral Solid Dose (OSD) packaging…
Added 6 hours ago
RU
Facilities Project Engineer
Randstad USA
Morris Plains, NJ
- $50 to $60 USD / hour
Join Our Client in an Onsite role as a Facilities Project Engineer in Morris Plains, NJ to drive transformative healthcare engineering! Requires BS in Engineering + 5+ yrs exp in GMP clean…
Added 6 hours ago
Area Manager
Ventura Foods
Chambersburg, PA
…communications, leading the triad including training lead and opex engineer, fuel for growth, people planning, staffing, and overall performance of an area. The Area Manager serves as the…
Added 8 hours ago
J
Validation Engineer
Jobgether
Remote, United States
- $110,000 to $125,000 USD / year
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Validation Engineer based in the United States.
Added 9 hours ago
Validation Engineer - Petoskey Area
The Pivot Group Network
Petoskey · Petoskey, MI
Regulatory Affairs Specialist, Quality Assurance Engineer, Quality Engineer, Process Validation Engineer, Equipment Qualification Engineer, Compliance Engineer, Manufacturing Quality…
Added 9 hours ago
Validation Engineer - Caro Area
The Pivot Group Network
Caro · Caro, MI
Equipment Qualification Engineer, Compliance Engineer, Manufacturing Quality Engineer, Test Engineer, Computer System Validation Specialist, Regulatory Affairs Specialist, Quality Assurance…
Added 9 hours ago
Validation Engineer - Cheboygan Area
The Pivot Group Network
Cheboygan · Cheboygan, MI
Regulatory Affairs Specialist, Quality Assurance Engineer, Quality Engineer, Process Validation Engineer, Equipment Qualification Engineer, Compliance Engineer, Manufacturing Quality…
Added 9 hours ago
Scientist/Engineer, Biologics Technical Operations - Lilly Medicine Foundry
Lilly
Indianapolis, IN · Lebanon, IN
The Scientist/Engineer – Technical Operations becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and serves as a key integrator with Process Engineering,…
Added 14 hours ago
Senior / Staff Software Engineer
Axella
Boston, MA
…delayed or lost - not because the science fails, but because process understanding and manufacturing execution break down somewhere along the way. It’s a systems problem more than a…

Validation & Engineering Group

Sr Quality Assurance (Validation) Engineer - FL, USA

Deerfield Beach, FL, United States

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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.

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