Senior Technical Services Manager

A Senior Technical Services Manager is required by CareerWise Recruitment for our Galway based client. As part of the Senior Technical Services function the Senior Technical Services Manager – Product/Process will be responsible for coordinating and supporting the Development & Optimization of Aseptic Pharmaceutical Manufacturing Processes, ensuring Compliance with Regulatory Standards, and driving continuous improvement initiatives as well as technical transfer and New Product Introductions. This role involves collaboratively providing input with cross-functional teams, including Production, Product Development, Quality, Regulatory and Engineering, to enhance efficiency, scale-up processes, perform NPIs and troubleshoot manufacturing challenges. 

THE ROLE:

Process Development & Optimization:

• Oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes, ensuring robust, scalable, and cost-effective production.
• Initiate and track the execution of process risk assessments (e.g., FMEA) and implement risk-mitigation strategies.
• Drive resolution for investigations into deviations, non-conformances, and root cause analyses.
• Lead technical aspects of scale-up, tech transfer, and commercialization of new products.

Validation & Compliance:

• Oversee the preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
• Provide direction and expertise in the generation of change controls aligned with site procedures to support product/process changes
• Ensure all process changes comply with cGMP, FDA, EMA, and other regulatory requirements.
• Provide SME support regulatory filings (e.g., CMC sections of regulatory filings) with process data and technical justifications.

Manufacturing Support & Troubleshooting:

• Manage on-the-floor technical support for routine manufacturing operations, deviations, and process issues.
• Collaborate with production and quality teams to ensure consistent process performance.
• Analyze process data trends to drive continuous improvement and reduce variability in critical quality attributes (CQAs).

NPI, Technical Transfer & Scale-Up:

• Guide and manage the technical requirements supporting technology transfers between development, pilot, and commercial-scale manufacturing.
• Collaborate with R&D, and Site Operations teams to ensure smooth process transitions.
• Provide SME level guidance regarding the definition of critical process parameters (CPPs) and critical quality attributes (CQAs) for robust transfer and/or scale-up.

Continuous Improvement & Innovation:

• Support team members in the identification and implementation of process improvements using Lean, Six Sigma, and other problem-solving methodologies.
• Evaluate and introduce new technologies to enhance efficiency, reduce waste, and improve yield.
• Support cost-reduction initiatives while maintaining quality and compliance.

REQUIREMENTS:

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
• 5 - 8 years of experience in pharmaceutical manufacturing, process engineering, or technical services.
• Experience in sterile injectables or biologics manufacturing.
• Technical Skills:
• Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.
• Experience with process validation (PPQ), DOE, and statistical process control (SPC).
• Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.
• Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc.
• Practical experience with filling machines, isolators, autoclaves, Depyrogenation tunnels, and Lyophilisers, modes of operation, critical process parameters etc.
• Good knowledge of aseptic behaviours, filter integrity testing, single use systems etc.
• Proficiency in data analysis tools (e.g., Minitab) and process modeling software.
• Microbiological fundamentals and knowledge of unit operations to secure sterility assurance.

• Soft Skills:
• Experienced in providing mentoring and direction to team members
• Track record of delivering projects, safely & compliantly
• Capability to set clear goals and manage multiple tasks
• 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:

• Six Sigma or Lean Manufacturing certification.
• Experience with automation systems (e.g., SCADA, MES).
• Knowledge of process analytical technology (PAT).

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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