Panda International

3 Jobs

113 Employees

About the Company

Behind every groundbreaking discovery in life sciences is a team of extraordinary people. At Panda, we connect that talent with organisations that are changing the world.

We are a Life Science recruitment consultancy specialising in biotechnology, medical devices, and pharmaceuticals where trust, expertise, and exceptional service are the foundation of everything we do.

Covering regional complexities whilst providing tailored talent solutions, we help clients and candidates meet their ambitions of both today and tomorrow.

Your organisation does extraordinary things every day. We help you find extraordinary people who make them happen.

Listed Jobs

Company Name: Panda International
Job Title: Analytical Validation Expert
Job Description: **Job Title:** Analytical Validation Expert **Role Summary:** Senior subject‑matter expert responsible for defining and governing analytical validation strategies for biopharmaceutical and advanced therapy medicinal product (ATMP) programs. Oversees GMP‑compliant method validation, method transfer, and quality assurance activities across MSAT, PAD, and QC laboratories while coaching teams and interfacing with clients and auditors. **Expectations:** - Minimum 5 years of senior experience in analytical validation/qualification. - MSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related life‑sciences discipline. - Fluency in English (written and spoken). **Key Responsibilities:** - Develop and implement analytical validation and qualification strategy aligned with ICH Q2 and lifecycle validation principles. - Draft, review, and maintain GMP‑compliant documentation (protocols, reports, SOPs). - Lead method transfer activities (client → QC/PAD/internal) ensuring transfer efficacy and reproducibility. - Manage deviations, out‑of‑specification (OOS) events, and invalid results, providing root‑cause analysis and corrective actions. - Conduct technical reviews and make data‑driven decisions on validation data. - Serve as client contact for analytical strategies, release testing plans, and audit readiness. - Mentor and coach MSAT/QC teams on validation practices and GMP requirements. **Required Skills:** - Deep knowledge of EU GMP and FDA guidelines for cGMP analytical work in biopharma/ATMP. - Proficiency in analytical method validation (ICH Q2, lifecycle validation). - Experience with statistical assessment of validation data and Total Error approach. - Strong scientific writing, data review, and technical decision‑making. - Familiarity with Analytical Quality by Design (aQbD) concepts. **Required Education & Certifications:** - MSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related field. - 5+ years of senior analytical validation experience; no specific certifications required.

Company Name: Panda International
Job Title: Project Manager - Engineering & Automation
Job Description: **Job Title:** Project Manager – Engineering & Automation **Role Summary:** Lead end‑to‑end engineering and automation projects in a GMP/GxP‑regulated CAR‑T manufacturing environment. Deliver technically robust, validated automation systems while managing scope, budget, risk, and stakeholder expectations. Drive continuous improvement and knowledge transfer to junior engineers. **Expectations:** - Deliver projects within defined scope, budget, and schedule. - Maintain compliance with GMP, GxP, and data integrity standards. - Communicate progress, risks, and mitigation plans to senior management and partners. - Foster a culture of safety, quality, and accountability. **Key Responsibilities:** - Own full project lifecycle: scope, schedule, cost, risk, and reporting. - Plan and prioritize engineering projects in alignment with departmental strategy. - Design, implement, and validate PLC, HMI, historian, and server‑hosted software for process equipment. - Ensure validation and qualification of automation systems meet regulatory requirements. - Resolve complex technical challenges affecting patient‑care operations. - Lead continuous improvement initiatives and gap analyses. - Train and mentor junior engineers, enhancing departmental capability. **Required Skills:** - Strong project management with 5+ years in leadership roles. - Expertise in automation engineering (PLC, HMI, historian) in GMP/GxP contexts. - Experience with qualification and validation of pharmaceutical systems. - Excellent stakeholder management and communication. - Structured problem‑solving, transparent decision‑making, and a safety‑first mindset. **Required Education & Certifications:** - Master’s degree in Engineering or equivalent professional experience. - Minimum 10 years of relevant experience in engineering and automation. - Project management certifications (PMP, PRINCE2) are an advantage.

Company Name: Panda International
Job Title: CSV Specialist - Validation/QA/Data Integrity
Job Description: **Job Title:** CSV Specialist – Validation/QA/Data Integrity **Role Summary:** Serve as the local Data Integrity Process Owner within a global life sciences supply chain organization, ensuring compliance of commercial and clinical systems across a major Belgian campus. Lead data integrity remediation, risk assessment, and regulatory readiness activities while collaborating with Engineering, IT, and cross‑functional teams. **Expectations:** - Master’s degree in a scientific discipline or equivalent professional experience. - Minimum 3 years within the pharmaceutical industry. - Proficiency in cGMP, CSV, and international data integrity guidelines (21 CFR Part 11, EudraLex Vol 4/Annex 11, GAMP 5). - Fluency in English and Dutch; strong ownership mindset. **Key Responsibilities:** - Own and continuously improve Data Integrity processes as Process Owner. - Assess local systems and equipment, identify risks, and lead remediation initiatives. - Conduct data flow mapping and perform platform‑based risk assessments for subject‑matter experts. - Represent Data Integrity matters during regulatory audits and inspections. - Collaborate with Engineering and IT on new system/introduction of processes to maintain compliance. - Drive a community of practice to promote a robust quality culture across multiple sites. - Lead multinational teams in defining risks and vulnerabilities for site‑specific equipment. **Required Skills:** - Knowledge of cGMP, CSV compliance, and 21 CFR Part 11 regulation. - Experience in Computerized System Validation and data integrity remediation. - Expertise in GAMP 5 and international data integrity guidelines. - Advanced data flow mapping and risk assessment capabilities. - Strong project management and cross‑functional team leadership. - Able to communicate effectively in English and Dutch. **Required Education & Certifications:** - Master’s degree in a scientific field (or equivalent professional experience). - Professional certifications in GAMP, CSV, or related quality assurance fields strongly preferred.