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Process Engineer

3 months ago

Laurel, Montana, 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 Process Engineerto support our projects in Mount Laurel, NJ.You will be responsible for Develop and execute process validation protocols and reports in accordance with regulatory requirements and industry best practices Manufacturing of liquid oral suspensions and solid oral dosage forms Perform risk assessments and gap analyses to identify areas for process improvement and ensure the reliability of manufacturing processes Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and other departments to support process validation activities Lead and/or participate in investigations related to process deviations, non-conformances, and CAPAs, and implement corrective and preventive actions as needed Support technology transfer activities between development and manufacturing sites, ensuring successful scale-up and transfer of processes Stay current with industry trends, regulatory requirements, and best practices related to process validation and contribute to the continuous improvement of validation processes and procedures Experience with risk assessment methodologies (e.g., FMEA) and statistical analysis tools (e.g., Minitab) is preferredAbout you Bachelor's or master's degree in engineering, Pharmaceutical Sciences, or related field Minimum of 5 years of experience in process validation within the pharmaceutical or biotechnology industry Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH) related to process validation.

Next StepsUpon 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 outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

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

Working at PQE GroupAs 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.