Quality Engineer
Quality Engineer
Posted on :
11-06-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-06-2025
Job Description
Responsibilities:
- Carry out all aspects of a validation project which includes authoring and executing Validation Master Plan (VMP) Validation Plan (VP) Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols/report in accordance with established procedures.
- Reviews approves and supports validation activities conducted by approved suppliers. Ensures validation records comply with regulatory and corporate requirements.
- Perform Validation Periodic Review for various systems including automated manufacturing equipment computerized systems and test equipment.
- Perform independent evaluation selection and application in making adaptations and modifications to projects.
- Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
- Manages and provides leadership for the functional groups development direction and effectiveness adhering to organizational policies and processes and supporting overall business and corporate objectives.
- Implements and understands FDA or regulatory requirements as necessary.
- Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
- Highlights risk and understand how to approach and complete tasks avoiding serious delays and considerable expenditure of time and resources.
- Advises team members pro-actively on technical ideas and promotes skill development of teamwork.
- Interacts with peers across projects to secure resources and commitments.
- Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
- Follows technical specification requirements and provides feedback on various technical processes and procedures.
- Presents effectively complex technical information/analysis and responds to questions from technical staff members and management.
- Works cooperatively and effectively within a team environment to achieve common goals and results often influencing the outcome of the team(s).
- Work direction responsibility may include technicians and junior engineers.
- May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
- Bachelors degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- Bachelor of Science Degree in Engineering preferred.
- Minimum 4 years experience.
- Two years of GMP manufacturing experience required.
- Requires demonstrated skills in technical innovation technical leadership mechanical and or chemical engineering fluids engineering and cellular biology.
- Strong interactive skills in general communication cross-functional participation and influence mentoring and acceptance of guidance technical leadership project management coordination with cross-functional team member team behaviors and support for subordinates junior engineers technicians and management.
- Strong technical problem-solving skills.
- Mechanical and electronic ability aptitude to assist with equipment troubleshooting.
- Understanding of and adherence to GMP practices and FDA regulations.
- Knowledge and ability to implement FDA or regulatory requirements as necessary.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
Employment Type
Full Time
Key Skills
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