QA Validation Engineer

Apply now
Job type
Contract
Location
North Carolina, United States
salary
Competitive
Ref. No
39054
QA Validation Engineer - North Carolina, United States - 9-months contract

Our client works across regulated sectors to build robust, repeatable compliance and validation practices. They prioritise clear guidance, clean documentation, and controls that fit how teams operate.
 

What you’ll do:

  • The QA Validation Specialist is responsible for implementing, executing, and assessing quality systems, procedures, and records to support compliant GMP operations.
  • The role works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.
  • Provide hands‑on QA support and oversight to internal teams and suppliers/contractors to ensure compliance with applicable quality standards, regulatory requirements, and industry guidance.
  • Review and approve commissioning, qualification, and validation documentation.
  • Review and approve qualification and validation deviations and discrepancies, supporting investigation and corrective actions.
  • Work collaboratively across site functions to instil a strong quality culture, coaching in the application of GMP principles and the rationale behind them.
  • Author, review, and approve controlled documents for Quality and other GMP functions, including SOPs, specifications, protocols, and reports.
  • Assist in the preparation for, and hosting of, regulatory inspections and audits as required.

What you’ll need:

  • Degree in biological, physical or chemical sciences, engineering, or a related field, with  experience in QA within biologics manufacturing. 
  • Strong knowledge of risk‑based approaches to qualification and validation in a biotech quality environment.
  • Hands‑on experience with qualification and validation of process equipment, isolators, bioreactors, clean utilities, automation systems, sterile filling, and cleanroom facilities.
  • Solid understanding of relevant regulations and guidelines, including US and EU frameworks (e.g. FDA, EMA), ICH guidance, and industry best practice.
  • Proven track record of working in a fast‑paced team environment, meeting deadlines, and prioritising work across multiple projects.
  • Strong analytical and communication skills, sound judgement, and the ability to work effectively with colleagues and stakeholders.
  • Excellent problem‑solving capability, with experience in root‑cause investigation and CAPA determination.

If this roles is of interest to you, apply today!


Apply now

Please complete the form for your job application, or feel free to reach out to our consultant directly for assistance.

Contact us

Mark Chaumeton
Client Services Manager
Mark Chaumeton

Jobs you might be interested in

MS&T Scientist

ContractDublin, County Dublin, Ireland

MS&T Scientist (Upstream or Downstream) - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for an MS&T Scientist for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Have a thorough knowledge of the science behind each molecule and associated drug substance manufacturing processes with fundamental knowledge of one or more of the following relevant principles.To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies (e.g. health authority query support - timely responses / data gathering etc.), representing the Cruiserath site.To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution. What you’ll need: Minimum BSc or equivalent with extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry.You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form. If this role is of interest, please apply now!#LI-JS4

Commercial Director

PermanentBerkhamsted, Hertfordshire, South East, England

Commercial Director – Berkhamsted, Hertfordshire – Excellent BenefitsWe have an amazing opportunity for a Delivery Executive to join our team in our UK office! At QCS Staffing, we’ve been delivering expert talent solutions in five of the world’s fasted growing sectors, and sourcing candidates from all over the globe for over 33 years!  With over 150 employees across our offices in the UK, US, and Europe, we are constantly on the hunt for eager individuals to join our team.What we provide: An inclusive ‘one team’ ethos, with endless socials, charity events and celebrations!Fantastic career progression opportunities, award-winning training and development programs (we invest in YOU)Private Healthcare & Pension planEarly finish on a FridayHybrid workingEnhanced maternity and paternity pay Paid parking  What you’ll do: Strategic Leadership: Develop and execute the commercial strategy to support the business in achieving its ambitious growth targets, working closely with the senior leadership team.Risk & Compliance Management: Ensure the business operates in full compliance with all relevant international laws, regulations, and industry standards.Contract Negotiation: Ensure all terms are commercially advantageous and legally sound.Operational Management: Oversee the daily operations of the three reporting business units to ensure efficiency, accuracy, and compliance. Implement best practices and streamline processes to support a high-growth environment.Team Management: Lead, mentor, and develop the Associate Director of Legal, and the heads of Compliance & Onboarding, and Contracts teams.Financial Oversight: Manage P&L responsibility for the reporting units, including budget planning and cost control.Stakeholder Relations: Build and maintain strong relationships with internal and external stakeholders, including clients, suppliers, and legal partners. Act as a key point of contact for key client accounts to manage complex commercial and legal matters. What you’ll need: Proven experience in a senior commercial or legal leadership role, such as Commercial Director, General Counsel, or Legal Director, within the international recruitment sector.A strong understanding of international contracts law and regulatory frameworks.Demonstrable track record of successfully leading commercial initiatives and managing a legal function in a high-growth environment.Exceptional leadership, negotiation, and communication skills.Law Degree - an MBA or equivalent business qualification is a significant advantage.The candidate must have the rights to work in the location stated in the job advert. If you're driven, curious, and love working with incredible people - apply now and grow with us!#LI-JP1