PDP | Talent Acquisition Specialist | Life Science Engineering | CQV & Project Controls
POSITION PURPOSE
As part of the Technical Services function the Technical Services Engineer – Equipment & Projects will be responsible for supporting the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing are qualified and maintained in a validated state.
This role involves developing and executing validation protocols (IQ, OQ, PQ), supporting regulatory compliance, and collaborating with cross-functional teams to ensure operational readiness.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Equipment Qualification & Validation
* Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
* Ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
* Perform risk assessments (e.g., FMEA) to determine validation strategies and critical parameters.
* Maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
Sterile Manufacturing Equipment & Systems
* Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
* Ensure validation of automation and control systems (SCADA, PLC, MES) where applicable.
Regulatory & Compliance Support
* Author and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
* Support audits and regulatory inspections by providing validation data and technical justifications.
* Ensure adherence to Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.
Deviation Management & Change Control
* Investigate validation deviations and non-conformances, implementing corrective and preventive actions (CAPAs).
* Assess the impact of equipment modifications and process changes on validated state.
* Collaborate with Manufacturing, Quality, and Engineering teams to ensure smooth execution of validation activities.
Continuous Improvement & Technology Upgrades
* Implement Lean and Six Sigma principles to optimize validation processes and reduce qualification cycle times.
* Support adoption of new technologies in aseptic processing, automation, and real-time monitoring.
* Evaluate requalification strategies and periodic review programs to ensure compliance and efficiency.
Perform other duties as assigned
QUALIFICATIONS & SKILLS
Education: Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
Experience: 5–7 years of experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
Technical Skills:
* Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
* Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
* Experience with validation lifecycle approach (URS, FAT/SAT, PQ).
* Knowledge of data integrity (ALCOA+ principles) and computerized system validation (CSV).
* Practical familiarity with environmental monitoring systems and cleanroom qualification.
* Knowledge of autoclave and depyrogenation tunnel operation
* Knowledge of load preparation – thermocouple calibration and placement.
* Handling of biological indicators
Soft Skills:
* Strong analytical and problem-solving skills.
* Excellent communication and cross-functional collaboration abilities.
* Ability to manage multiple projects in a fast-paced environment.
Preferred Qualifications
* Knowledge/familiarity of endotoxin spiking procedure – could help with micro resource shortage with respect to depyrogenation tunnel qualification
* Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
* Familiarity with Process Analytical Technology (PAT) and digital validation tools.
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