Senior Consultant

Company Description

KSP Consulting is on a great growth trajectory and continuously building a strong team.

We provide services in Engineering, Commissioning, Qualification, Validation, and Business Consulting across diverse industries and locations. KSP Consulting is committed to building a strong, collaborative team that delivers customized solutions for each client problem, acting and executing quickly without compromising quality. Its mission centers on supporting compliance in drug manufacturing to ensure product quality is never sacrificed due to time or cost pressures.

The organization is driven by five core values:
Adaptability, Innovation, Determination, Teamwork, and Integrity.

We have Three full-time positions and the team will expand further with some junior consultants. This is strictly on-site Senior Consultant role based in Rahway, NJ
. The Senior Consultant will lead and deliver specific project scope for Drug substance manufacturing and equipment including Bioreactor, Centrifuge, Sterile Fill Finish project that includes process equipment such as Vial washer, Depyro tunnel, Autoclave, Filling machine, TFF and sterile filtration. Also includes Drug product equipment such as Isolator, automated visual inspection machine and Lyophilizer commissioning and qualification.

This can be a full time or contract position depending on the experience and candidate's commitment for such project.

• Demonstrated expertise in engineering, commissioning, qualification, and validation within regulated or manufacturing environments.
• Strong consulting skills, including client needs assessment, solution design, and business process improvement.
• Solid understanding of regulatory compliance and quality systems related to drug manufacturing or life sciences.
• Direct experience with strategy development for CQV scope, developing protocols and field execution of approved protocols.
• Candidate will be supporting data review, deviation investigation, binder compilation and summary reports.
• Excellent written and verbal communication skills, with the ability to present complex concepts clearly to diverse stakeholders.
• Collaborative mindset with proven experience working in cross-functional teams and mentoring less-experienced colleagues.
• Bachelor's degree in Engineering, Life Sciences, Business, or a related field; an advanced degree or relevant certifications (e.g., PMP, CQV, quality or regulatory certifications) are a plus.
• Demonstrated alignment with core values such as adaptability, innovation, determination, teamwork, and integrity.
• Experience in startup or high-growth consulting environments is beneficial, as is prior work in global or multi-site projects.
• Flexibility for long hours and shift work which will include some weekend support as well.