Engineer Validation

Satara - India

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

In billions of syringes and in every second car worldwide Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality system-critical elastomer components and holds leading positions in attractive global markets such as healthcare mobility connectivity general industry and food & beverage. With over 25 production sites on four continents sales in more than 100 countries and over 8000 employees the company headquartered in Switzerland generates annual sales of more than CHF 1000 million.

Our employees are the heart of Datwyler - we treat each other with respect trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Goal

This role assumes a good understanding and knowledge of regulatory guidelines that apply to validation of equipment utilities and computerised systems. Maintaining documentation integrity conducting risk assessments and staying abreast of industry regulations to ensure continuous compliance.

Responsibilities

Maintains equipment validation master plans (VMP) traceability matrices test case protocols test cases validation reports and summary reports for Datwyler operating equipment.
Determine validation approach for projects write project validation plan (PVP) .
Ensure and maintains validation status of cleanroom water system cleaning validation washing validation.
Reviews completed validation documentations (URS QCDS FAT SAT PQ etc.) to ensure actual results meet expected results.
Ensures that all validation deviations are resolved documented and reviewed for regression testing
Oversees the review of operating equipment changes including impact assessment and presents to relevant management.
Defines and develops validation schedules to ensure that all Datwyler production equipment are periodically reviewed and assessed for revalidation
Develops reviews and revises standard operating procedures (SOPs) consistent with ISO ASTM-2500E and European Union (EU) regulations and customer requirements.
Develops processes to maintain validated equipment status per the approved VMP.
Provides technical support during internal/external audits and regulatory inspections.
To work closely with all department and the Quality Department to ensure the operation of a validated environment according to GMP and regulatory requirement.
Manage database for SOPs and validation documents (Pilgrim and Lotus Note) with proper tracking for timely closure of documents
Develops reviews and revises standard operating procedures (SOPs) consistent with ISO ASTM-2500E and European Union (EU) regulations and customer requirements.
To continue to develop and implement an efficient complaint and cost effective calibration and maintenance program for GMP critical manufacturing equipments
Coordinate calibration activities among the cross function team including external parties Review calibration records and maintained as per ISO/IEC 17025 guideline.
Participate in different (Global/Local projects).

Profile

B. Pharma / M. Pharma /
2 to 4 years experienced

Country specific section

India (On-Site)

Your Position1

Your Position2 (Optional)

Our Offer to you

Datwyler Competencies

Datwyler Leadership Competencies -Ensuring Responsibility/Integrity- Calls for ownership -Level 3

Datwyler Social & Personal Competencies - Team orientation- Is a team player - Level 4

Datwyler Management Competencies- Entrepreneurship- Implements strategy - Level 3

Datwyler Leadership Competencies- Adaptability- Participates in change- Level 3

Datwyler Social & Personal Competencies-Dealing with socio-cultural diversity- Respects diversity-Level 4

Datwyler Management Competencies - Result Orientation and Execution - Implements objectives - Level 3

Datwyler Expertise Competencies- Business orientation - Pursues KPIs-Level 3

Datwyler Expertise Competencies- Exceed customer expectations - Understands the customer-Level 3

Datwyler Management Competencies - Creativity and Innovation - Produces a wide range of ideas -Level 3

Datwyler Social & Personal Competencies- Emotional Intelligence- Is responsive to the situation of others-Level 3

Datwyler Expertise Competencies- Professional aptitude- Is able to instruct others-Level 3

Datwyler Leadership Competencies- Lead by coaching - Installs opportunities to develop- Level 3

Skills

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler you will experience diversity and a wide range of career opportunities that only an international company can provide. Together we are increasing our agility accelerating digitalization and fostering sustainability. For motivated and talented employees we offer interesting development opportunities with training and assignments in a global environment. With us you can contribute with all of your creativity and all your ideas.

Goal

Responsibilities

Maintains equipment validation master plans (VMP) traceability matrices test case protocols test cases validation reports and summary reports for Datwyler operating equipment.
Determine validation approach for projects write project validation plan (PVP) .
Ensure and maintains validation status of cleanroom water system cleaning validation washing validation.
Reviews completed validation documentations (URS QCDS FAT SAT PQ etc.) to ensure actual results meet expected results.
Ensures that all validation deviations are resolved documented and reviewed for regression testing
Oversees the review of operating equipment changes including impact assessment and presents to relevant management.
Defines and develops validation schedules to ensure that all Datwyler production equipment are periodically reviewed and assessed for revalidation
Develops reviews and revises standard operating procedures (SOPs) consistent with ISO ASTM-2500E and European Union (EU) regulations and customer requirements.
Develops processes to maintain validated equipment status per the approved VMP.
Provides technical support during internal/external audits and regulatory inspections.
To work closely with all department and the Quality Department to ensure the operation of a validated environment according to GMP and regulatory requirement.
Manage database for SOPs and validation documents (Pilgrim and Lotus Note) with proper tracking for timely closure of documents
Develops reviews and revises standard operating procedures (SOPs) consistent with ISO ASTM-2500E and European Union (EU) regulations and customer requirements.
To continue to develop and implement an efficient complaint and cost effective calibration and maintenance program for GMP critical manufacturing equipments
Coordinate calibration activities among the cross function team including external parties Review calibration records and maintained as per ISO/IEC 17025 guideline.
Participate in different (Global/Local projects).

Profile

B. Pharma / M. Pharma /
2 to 4 years experienced