Technical Project Manager

As a Technical Project Manager you will join our Hertfordshire team to support our activities within the pharmaceutical manufacturing sector.

You will be responsible for leading and managing technical projects across the Quality Control laboratory ensuring laboratory systems equipment and processes remain compliant efficient and fit for purpose. Working closely with Quality IT Manufacturing and external stakeholders you will oversee electronic laboratory systems equipment lifecycle management method transfers new product introduction activities and laboratory compliance initiatives within a GMP-regulated environment.

• Location:
  Hertforshire
• On Site:
  Full - time on site
• Clearance:
  Clearable
• Experience Level: Senior (5 years)

Key Responsibilities:

• Lead and manage all technical projects within the Quality Control laboratory
• Manage and develop a team of technical specialists supporting laboratory systems and equipment
• Oversee the lifecycle management of QC electronic systems including LIMS CDS and associated laboratory software
• Ensure laboratory equipment and systems remain compliant with GMP Data Integrity requirements and company procedures
• Develop and maintain a five-year equipment replacement and investment plan
• Lead New Product Introduction (NPI) and Method Transfer activities within the QC function
• Manage compliance-related initiatives including global changes pharmacopeia updates and regulatory requirements
• Drive change management activities to ensure laboratory systems and equipment remain operational and compliant
• Review and approve SOPs quality documents and technical procedures
• Coordinate education and training programmes relating to specialist equipment and software
• Work with cross-functional stakeholders to deliver technical improvements and laboratory optimisation projects
• Monitor project progress risks budgets and resource requirements
• Support inspections audits and regulatory interactions as required

Qualifications :

Required Skills:

• Strong knowledge of pharmaceutical Quality Control laboratory operations
• Experience managing QC equipment and electronic laboratory systems
• Knowledge of LIMS CDS and laboratory software platforms
• Understanding of equipment qualification validation and lifecycle management
• Experience leading technical projects within a regulated environment
• Strong understanding of GMP requirements and Data Integrity principles
• Excellent communication stakeholder management and leadership skills
• Ability to gather analyse and translate user requirements into practical solutions
• Strong organisational and project management capabilities
• Ability to interpret complex technical and scientific information and communicate findings effectively

Required Qualifications:

• A Bachelors or Masters degree in Engineering or equivalent military experience.
• Significant experience working within a pharmaceutical Quality Control laboratory environment
• At least 2 years of experience managing QC equipment and electronic laboratory systems
• Experience supporting technical change validation qualification or laboratory compliance activities

Desirable Skills:

• Experience as a LIMS or CDS administrator
• Knowledge of laboratory instrument qualification and computer system validation (CSV)
• Experience supporting method transfers and analytical technology implementation
• Familiarity with pharmacopeia compliance activities and regulatory submissions
• Experience managing multidisciplinary technical teams
• Understanding of continuous improvement and laboratory digitalisation initiatives
• Knowledge of laboratory automation technologies

Additional Information :

Why join us

We bring together entrepreneurial tech-driven people to deliver innovative solutions for leading companies.

At ALTEN youll work on exciting projects supported by ongoing learning…