Senior Validation Engineer
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Job Location:
Devens, MA - USA
Yearly Salary:
$ 96366 - 131886
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Job Title:Senior Validation Engineer
City:Devens
State: MA
JOB DESCRIPTION:
Validation
- Generate execute review finalize and approve validation/qualification protocols.
- Manage and update the validation master plan to align with best industry practices.
- Assist and deliver amendments to the qualification(s) to ensure qualification compliance within deadlines.
- Provide validation/qualification support to quality assurance during audits and during deviation investigations.
- Utilize computerized asset management system for managing validation/qualification schedules.
- Generate operational and maintenance SOPs FATs URSs FRSs validation protocols and reports.
- Source hire and manage general contractors or other validation engineers.
- Train and mentor the local teams on validation approaches protocols and execution of protocols. Oversee generation and execution of qualification documents by employees outside of the Validation/Engineering department.
- Manage the calibration and maintenance of validation equipment.
- Attend vendor FAT (Factory Acceptance Tests).
- Work with other departments to develop equipment specifications and process system designs.
Project
- Generate and manage project timelines including proper resourcing for future qualifications.
- Investigation and resolution of equipment and system problems.
- Represent the validation/qualification department during safety/quality audits.
- Assist in the calibration adjustment and modification of plant and lab process instrumentation.
- Manage several projects simultaneously.
General
- Perform all of the foregoing within pharmaceutical/chemical manufacturing industry specifically related to equipment validation on calibration according to GMP standards and internal standard operating procedures.
- Work safely injury free and participate in improving department and site safety performance.
- Provide technical support to the Maintenance Production Lab and Calibration departments.
- Aid in continuously improving the efficiency and effectiveness of the system.
EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Bachelors degree in Chemical Engineering and 3 years of experience in job offered or 3 years of experience in the Related Occupation.
RELATED OCCUPATION:
Validation Engineer or any other job title performing the following job duties:
- Led cross-functional teams to develop optimize and implement process improvements ensuring compliance with industry regulations and best practices.
- Developed and executed testing protocols for process equipment utilities and systems.
- Managed activities for manufacturing processes ensuring adherence to quality standards and regulatory requirements.
- Conducted root cause analysis and implemented corrective and preventive actions (CAPA) to resolve process deviations and enhance operational efficiency.
- Collaborated with engineering production and quality teams to streamline workflows reduce cycle times and improve production capacity.
- Utilized Lean Manufacturing and Six Sigma methodologies to optimize processes improve efficiency and reduce costs.
- Authored and maintained standard operating procedures (SOPs) work instructions and technical documentation to support operational and regulatory compliance.
- Monitored and analyzed key process performance indicators identifying opportunities for continuous improvement.
- Assisted in regulatory inspections and audits by ensuring process documentation and/or validation activities met compliance requirements.
- Implemented data-driven decision-making strategies using statistical tools and analysis to enhance product quality and process reliability.
SALARY RANGE: $96366.00 to $131886.00/year
JOB TIME: Full Time
#LI-DNI
Required Experience:
Senior IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Veranova is a global leader in the development and manufacturing of specialist and complex API ingredients for pharma and biotech customers.
