Quality Engineering and Validation

Stark Pharma Solutions Inc; Boston (MA); On-site; USD 95,000 - 130,000; Full time

Job summary

Vakula Tech Inc. is hiring a Quality Engineering and Validation professional for a long-term role in Boston, MA. The candidate will provide QA oversight for GMP manufacturing operations and support validation activities across clinical and commercial drug product production.

The ideal candidate has experience with aseptic processing, investigations, CAPA, and quality systems. Strong communication and cross-functional collaboration skills are essential for timely issue resolution.

Qualifications

• Master's degree with 3-5 years of relevant experience, or Bachelor's degree in Engineering, Scientific, or related field with 8+ years of relevant experience.
• Experience providing QA support for GMP manufacturing operations and validation activities.
• Experience with aseptic processing, investigations, root cause analysis, and CAPA.
• Knowledge of GMP regulations, quality systems, and risk-based decision making.
• Experience with quality management systems such as Veeva, Nuvolo, ViewLinc.
• Strong communication, collaboration, problem-solving, and organizational skills.

Responsibilities

• Provide QA oversight and support for GMP manufacturing operations and capital projects.
• Support validation activities, change controls, risk assessments, GMP investigations, and CAPAs.
• Identify quality risks and ensure compliance with GMP processes and quality systems.
• Review calibration records, preventive maintenance, work orders, and laboratory instrument qualification activities.
• Review and approve equipment, facility, and utility trending programs.
• Support environmental monitoring, routine testing, and facility control programs.
• Collaborate with cross-functional teams to ensure quality compliance and timely issue resolution.

Skills

QA oversight

GMP knowledge

Communication

Problem solving

Collaboration

Education

Master's degree in Engineering/Science

Bachelor's degree + 8+ years experience

Tools

Veeva

Nuvolo

ViewLinc

Job description

We are hiring talented professionals for our client.

Position:

Quality Engineering and Validation

Location:

Boston, MA

Duration:

Long Term

Job Overview

We are seeking a Quality Engineering and Validation professional to provide quality oversight and GMP compliance support for clinical and commercial drug product manufacturing operations. The ideal candidate will have experience supporting GMP manufacturing, validation activities, investigations, and quality systems within a regulated life sciences environment.

Key Responsibilities

• Provide QA oversight and support for GMP manufacturing operations and capital projects.


• Support validation activities, change controls, risk assessments, GMP investigations, and CAPAs.


• Identify quality risks and ensure compliance with GMP processes and quality systems.


• Review calibration records, preventive maintenance, work orders, and laboratory instrument qualification activities.


• Review and approve equipment, facility, and utility trending programs.


• Support environmental monitoring, routine testing, and facility control programs.


• Collaborate with cross-functional teams to ensure quality compliance and timely issue resolution.

Required Qualifications

• Master's degree with 3 5 years of relevant experience, or Bachelor's degree in Engineering, Scientific, or related field with 8+ years of relevant experience.


• Experience providing QA support for GMP manufacturing operations and validation activities.


• Experience with aseptic processing, investigations, root cause analysis, and CAPA.


• Knowledge of GMP regulations, quality systems, and risk-based decision making.


• Experience with Veeva, Nuvolo, ViewLinc, or similar quality management systems.


• Strong communication, collaboration, problem-solving, and organizational skills.

Sravani Dasari
Talent Acquisition Specialist
Vakula Tech Inc.
Email: [e-mail]
Piscataway, New Jersey 08854
Website: www.vakulatech.com