Automation Validation Engineer - Pharmaceutical Equipment
Warminster , PA
Experience: 6
Education: BA
Category: Scientific & Clinical,Engineering
Brand: Joulé
Job ID: 319294
Date Posted: 06/24/2024
Shortcut: http://jobs.systemone.com/Rd8GlZ
Title: Automation Validation Engineer - Pharmaceutical Production Equipment
Location: Warminster, PA (On site)
Type: 6+ Month Contract potential for extension or hire
Schedule: Mon-Fri Day
Overview: Growing Life Science Company is seeking an Automation Validation Engineering Professional to develop and execute validation plans and tests for new pharma processing equipment. The ideal candidate will have a strong background in validation methodologies, experience in the pharmaceutical industry, and experience crafting processes and validation protocols.
Responsibilities:
- Develop and execute validation protocols for pharmaceutical equipment, including systems and software validation, in accordance with regulatory requirements such as FDA, EU GMP, and ISO standards.
- Collaborate with cross-functional teams including engineering, quality assurance, and regulatory affairs to ensure validation activities are completed effectively and efficiently.
- Perform risk assessments to identify potential hazards and develop mitigation strategies for validation activities.
- Conduct testing and analysis to verify that equipment meets performance specifications and functional requirements.
- Generate comprehensive validation documentation, including protocols, reports, and traceability matrices, ensuring accuracy and compliance with regulatory standards.
- Provide support during regulatory inspections and audits by presenting validation documentation and addressing any inquiries related to validation activities.
- Stay informed about industry trends and regulatory changes related to validation practices and implement best practices to continuously improve validation processes.
Qualifications:
- Bachelor's degree in engineering, pharmaceutical sciences, or related field; advanced degree preferred.
- Minimum of 5 years of experience in developing validation plans and protocols within the pharmaceutical industry, preferably in equipment manufacturing or OEM environment.
- Strong understanding of regulatory requirements for pharmaceutical validation, including FDA 21 CFR Part 11, EU Annex 11, and GAMP guidelines.
- Proficiency in validation methodologies such as IQ/OQ/PQ, risk assessment, and validation lifecycle management.
- Experience with validation of complex systems and software applications used in pharmaceutical equipment.
- Excellent analytical and problem-solving skills, with the ability to troubleshoot technical issues and propose effective solutions.
- Exceptional communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders.
- Detail-oriented with a commitment to producing high-quality validation documentation that meets regulatory standards.
- Ability to work independently with minimal supervision and manage multiple projects simultaneously
#LI-GS1
#M3
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
-
Mechanical Field Engineer
Denver, Colorado
We are seeking a highly skilled Mechanical Engineer with specialized experience in refinery operations for field installation work at our Denver Refinery site. Responsibilities: Provide expertise in the installation, maintenance, and troubleshooting of...
Date Posted: 06/20/2024 Recommended
-
Director of Quality
Lakewood, CO
Title: Director of Product Quality Location: Littleton, Co Type: Direct/Permanent Salary Range: $177,400.00 to $221,700.00 + 30% bonus and LTIs Start date: Immediate Are you a seasoned quality leader with experience in high-volume, highly automated man...
Date Posted: 05/28/2024 Recommended
-
Senior Project Manager
Voorhess, NJ
POSITION SUMMARY As the Senior Project Manager, you will serve as the technical lead for design execution of projects. You will oversee all project design activities and serve as the primary point of contact for the client on the project. You will also...
Date Posted: 05/07/2024 Recommended
-
Principal Automation Manufacturing Engineer
Lakewood, CO
Job Title: Senior Automation Manufacturing Engineer Location: Littleton, CO Type: Full Time, Salaried with benefits Pay: $140,000 - $190,000/year based on industry experience, technical knowledge and skills Overview: Our client is seeking a highly expe...
Date Posted: 06/19/2024 Recommended
-
Validation Engineer
Summit, NJ
Job Title: Validation Engineer Location: Summit, NJ Type: Contract Responsibilities Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification protocols, and associated reports while adhering to...
Date Posted: 05/07/2024 Recommended
-
I&C Systems Design Engineer, Remote
Bellevue, WA
I&C System Design Engineer, 100% Remote No C2C No visa sponsorship This position reports directly to the System Design Manager. In this role, you will act as I&C Engineer for Sodium Fast Reactor technologies, including responsibility for the instrument...
Date Posted: 06/24/2024 Recommended
-
Instrumentation & Controls Engineer
Greentree, Pennsylvania
System One is seeking a Lead Instrumentation & Controls Engineer to develop I&C deliverables for all phases of a project to ensure that applicable codes, standards, and procedures are followed, and quality is acceptable. This is a great opportunity to ...
Date Posted: 05/02/2024 Recommended
-
Project Engineer
Amelia, Louisiana
Duties and Responsibilities Responsibilities and duties will include, but are not limited to: Participate in project kick-off meetings to review schedule, build strategy, and project specific information. Develop and maintain project Document Logs, Req...
Date Posted: 06/25/2024 Recommended
-
Project Coordinator
Bellevue, WA
Remote, long-term contract opportunity! System One is seeking a Project Coordinator who will focus on the management of engineering design activities, coordination of interfaces between project teams, and facilitation of engineering work planning and t...
Date Posted: 06/24/2024 Recommended
-
Manufacturing Systems Engineer
York, PA
Direct hire opportunity for an excellent company headquartered in York, PA. Systems Engineer Job Objective The System Engineer is the primary engineering resource for one or more concurrent system jobs. Duties include some project management of each jo...
Date Posted: 06/13/2024 Recommended
-
Senior Project Manager
Princeton, NJ
POSITION SUMMARY As the Senior Project Manager, you will serve as the technical lead for design execution of projects. You will oversee all project design activities and serve as the primary point of contact for the client on the project. You will also...
Date Posted: 05/07/2024 Recommended
-
Electrical Department manager
Warrendale, PA
Electrical Engineering Manager Job Purpose: Responsible for managerial direction of the department. Provides supervision and guidance related to overall objectives, critical issues, new concepts, and policy matters. Determines technical and professiona...
Date Posted: 05/07/2024 Recommended
-
Lead Electrical Engineer
Salt Lake City, Utah
Lead Electrical Engineer As a Lead Project Electrical Engineer, you will be a viable member of a team focused on creating highly efficient design plans for building state-of-the-art passenger trains. Key Activities Support the Technical Project Manager...
Date Posted: 05/30/2024 Recommended
-
Sr. Process Engineer
Lake Mary, FL
System One is seeking a Sr. Process Engineer for a direct hire opportunity in Lake Mary Florida. We are seeking a Senior Process Engineer to lead the process design functions of our hydrogen infrastructure and project development team. This includes pr...
Date Posted: 06/17/2024 Recommended
-
Lead Electrical Engineer
Spring Grove , PA
Lead Electrical Engineer-Electrical & Instrumentation Position Type: Full-Time, Direct Hire (Permanent) Role This position is responsible for supporting the business in Electrical and Instrumentation Engineering for the facility. The primary roles of t...
Date Posted: 06/13/2024 Recommended