What are the responsibilities and job description for the Manufacturing Deviations Investigator position at TekWissen ®?
Overview
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, and cell and gene therapy, the company provides comprehensive services across the pharmaceutical, biotech, and life sciences sectors. It supports every stage of drug development, from early research to commercial production, and offers solutions in biologics, small molecules, and specialty ingredients. Committed to quality and innovation, the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes, with a global presence that ensures access to scalable, flexible, and compliant technical expertise.
Job Title: Manufacturing Deviations Investigator
Location: Portsmouth, NH - 03801
Duration: 7 Months
Job Type: Temporary Position
Work Type: Onsite
Summary
Deviation Investigator Level I–III / Manufacturing Deviations Investigator is responsible for investigating and completing deviation cases to identify root causes and implement corrective and preventive actions (CAPA) to avoid recurrence. At higher levels (Level III), the role involves working in a cGMP environment with knowledge of mammalian manufacturing processes, handling multiple projects simultaneously, and demonstrating strong technical writing, facilitation, and compliance-oriented investigation practices.
The position also contributes to building sustainable, high-performing investigation teams through knowledge sharing and continuous improvement.
Responsibilities
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, and cell and gene therapy, the company provides comprehensive services across the pharmaceutical, biotech, and life sciences sectors. It supports every stage of drug development, from early research to commercial production, and offers solutions in biologics, small molecules, and specialty ingredients. Committed to quality and innovation, the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes, with a global presence that ensures access to scalable, flexible, and compliant technical expertise.
Job Title: Manufacturing Deviations Investigator
Location: Portsmouth, NH - 03801
Duration: 7 Months
Job Type: Temporary Position
Work Type: Onsite
Summary
Deviation Investigator Level I–III / Manufacturing Deviations Investigator is responsible for investigating and completing deviation cases to identify root causes and implement corrective and preventive actions (CAPA) to avoid recurrence. At higher levels (Level III), the role involves working in a cGMP environment with knowledge of mammalian manufacturing processes, handling multiple projects simultaneously, and demonstrating strong technical writing, facilitation, and compliance-oriented investigation practices.
The position also contributes to building sustainable, high-performing investigation teams through knowledge sharing and continuous improvement.
Responsibilities
- Conduct deviation investigations and ensure timely completion.
- Identify root causes and implement effective CAPA to prevent recurrence.
- Make real-time decisions for deviation containment and investigative actions.
- Manage moderate to high workload with consistent on-time delivery.
- Resume and drive ongoing investigations with minimal supervision.
- Provide direction and guidance to investigation teams on deviation approach.
- Facilitate knowledge transfer to enhance team expertise.
- Achieve ~80% Right First Time (RFT) on customer deviation reviews.
- Handle complex investigations with support from leadership when required.
- Perform additional duties as assigned.
- Experience working in a cGMP environment
- Knowledge of CAPA processes
- Strong technical writing skills
- Experience mentoring or guiding investigation teams
- Ability to manage multiple projects simultaneously
- Ability to build and sustain high-performing teams
- Strong decision-making in real-time scenarios
- Continuous improvement and knowledge-sharing mindset
- Strong investigation and root cause analysis skills
- Good meeting facilitation and conflict resolution abilities
- Ability to work independently with minimal supervision
- Strong time management and delivery focus
- Compliance-oriented mindset
- Knowledge of mammalian manufacturing processes
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.
Salary : $30 - $45