7 Jobs in WARMINSTER, PA
System One is Hiring a Test Automation Engineer Near Warminster, PA
Location: Warminster, PA
Type: 6 Month Contract potential for extension or hire
Schedule: Mon-Fri Day
Overview: Growing Pharmaceutical 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.
- 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
Job Summary
Contractor
Business Services
$106k-126k (estimate)
04/28/2024
07/25/2024
healthsystemone.com
MIAMI, FL
25 - 50
Private
JOSEPH BRUCE
$10M - $50M
Business Services
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The job skills required for Test Automation Engineer include Analysis, Problem Solving, Quality Assurance, Communication Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a Test Automation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Test Automation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Test Automation Engineer positions, which can be used as a reference in future career path planning. As a Test Automation Engineer, it can be promoted into senior positions as a Test Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Test Automation Engineer. You can explore the career advancement for a Test Automation Engineer below and select your interested title to get hiring information.
