CQV Principal Consultant

1 month ago

Boulder, United States PQE Group Full time
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a CQV Principal Consultant with 15+ years of experience with Commissioning, Qualification and Validation of process equipment, utilities and automation computerized systems in API manufacturing and Peptides Processing facilities fitting the following mandatory skill-set and willing to work in Boulder (Colorado) area:
 
You will be responsible for:
  • Developing CQV strategies/approaches for three strategic capital projects, with retrofitting of existing facilities and integration of new systems and processes into the existing infrastructure with minimal disruption to ongoing operations (CQV timeline to meet the ambitious 2026 production start date).
  • Writing of Programmatic Validation Master Plan that identifies opportunities to enhance harmonization of protocols and related workstreams across all capital projects and assesses current vs future state considerations (policies, procedures, systems and execution methodologies), highlighting gaps and control measures to achieve best-in-class applications across all workstreams.
  • Technical coordination of a team of Technical Writers in developing individual Validation Project Plans for each of the three capital projects, describing the validation approach for the facilities, utilities, equipment and processes associated with the projects.
  • Coordination with the existing facility's operational teams to ensure compliance with current operational standards and regulatory requirements.
  • Detailed commissioning and qualification planning for retrofitted systems, ensuring they meet GMP and FDA standards.
  • Reviewing all team members edits vs. Regulatory/Client's expectations, industry guidances and applicable SOPs.
  • Proposing solutions to sort out Quality vs. Time vs. Costs issues.
  • Reporting periodically (weekly and monthly, as appropriate) to Client Sponsor / PMO and PQE Operations Board about project status/achievements, handling issues/conflicts (goal is of course to preventing them, as much as possible).
  • Leading the project interacting with key Client sponsor(s) and stakeholders to collect all applicable business and quality requirements.
 
About you:
  • A bachelor’s degree in STEM or another relevant academic discipline.
  • Experience working in a fast-paced environment requiring quality contribution on multiple critical projects.
  • Deep knowledge of API manufacturing and Peptides processing
  • Experience authoring and reviewing strategic validation lifecycle documents.
  • Deep knowledge of cGMP, Good Documentation Practices and ALCOA++ data integrity principles.
  • Demonstrated ability to work independently and collaboratively in cross-functional teams and open to learn and adapt to changing demands.
  • Strong communication skills (verbal and written). 
  • Management of capital CQV projects
 
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal.

Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Workin at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.

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