What are the responsibilities and job description for the Validation Engineer position at MB&A?
The
Validation Engineer – Olive Branch will play a pivotal role in overseeing and
optimizing all aspects of our Olive Branch Validation programs. The position is responsible for process
development, maintenance and risk mitigation while ensuring execution of
deliverables, communication and fostering a culture of collaboration and
continuous improvement.
Key
Responsibilities
- Responsibility for targeted
planning, optimization and implementation of qualifications and (re)validations
of production facilities and manufacturing processes in accordance with the management systems (EN ISO 13485, 21 CFR-Part 820), including protocol
and process generation taking into account applicable quality standards.
- Perform gap assessments with respect to Site
Master Validation Plan.
- Carry out and implement assigned Tasks, Projects, (re)validations, risk
analysis per ISO 14971, compliance monitoring, capability studies and prepare
statistical evaluations.
- Author validation plans, IQ, OQ, PQ protocols
and reports along with updating current state company process documentation to ensure
compliance with current internal and external regulations.
- Evaluation of change
requests, non-conformances, deviations and CAPA with regard to qualification and validation requirements.
- Communicate, Coordinate and
Manage Change Control with our Customers as well as implementation of changes
into production.
- Maximize uptime for Operations while ensuring
spare parts and redundancy measures are in place.
- Manage and Optimize facility Calibration initiatives.
- Support and execute design controls, process
controls to hazardous situations, complaints, non-conformances on cross
functional teams.
- Consult executive leadership on risk
management process defining a robust and sustainable approach to FMEA including
sustainable approaches to product lifecycle risk management.
- Develop and Deploy training for the
remediation program for performing gap analysis activities for IQ, OQ, PQ.
- Subject matter expert for
software applications and qualification and validation topics including but not
limited to root cause analysis, remediation, impact assessments for new
processes, documentation and audits inside the Quality Management System.
Requirements
- Bachelor’s
degree in the field of mechanical
engineering, process engineering or a comparable technical education.
- Proven Track record and
proficiency in Design and Process Controls, Process Qualification and
Validation requirements.
- Knowledge
of industry regulations and manufacturing standards and guidelines for medical devices, including DIN ISO
13485, 21 CFR Part 820, GMP Annex 15 and DIN EN ISO 14971.
- Knowledge in validation
of computerized systems and software according to 21 CFR Part 11, ISO13485,
GMP Annex 11, ISO 14971, EUMDR and GAMP 5.
- Strong knowledge of MS Excel,
Macro creation and statistical methods (e.g. Minitab)
- Strong
problem-solving and Analytical skills.
- Excellent
communication, teamwork, interpersonal abilities and solution-oriented
Note: This position does not offer a relocation package or sponsorship. Candidates must be located in Olive Branch, Mississippi or be willing to relocate at their own expense.