Snr/Validation Specialist (Drug Product)

Hilleman Labs; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Hilleman Labs is seeking a Senior/Validation Specialist (Drug Product) to lead qualification and validation activities for biologics and vaccines in clinical manufacturing. You will focus on DP fill/finish, equipment PQs, cleaning and process validations, and maintain inspection-ready records.

The role requires a strong background in DP qualification/validation, aseptic processing, and robust document control, with experience coordinating multiple stakeholders to meet milestones and regulatory

Qualifications

• BSc/MSc in engineering or life sciences with relevant industry experience.
• Experience in DP/fill and finish qualification/validation activities.
• Knowledge of GMP and validation concepts and documentation.

Responsibilities

• Develop qualification/validation documents and plans for DP fill/finish lines.
• Execute validation activities including PQs, cleaning and process validation.
• Coordinate with internal and external stakeholders for samples and results.
• Prepare inspection-ready qualification/validation documentation for audits.

Skills

GMP

Qualification/Validation

Project coordination

Team collaboration

Education

BSc/MSc in engineering/science

Tools

Kaye validators

GMP equipment

Job description

Snr/Validation Specialist (Drug Product)

Reports to : Senior Manager, Technical Services and Validation

Objectives:

• Carry out qualification/validation activities associated with the manufacture of biologics and vaccines at the clinical manufacturing facility, focusing on Drug product fill and finish line
• Responsible for completing milestones related to validation deliverables such as commissioning, qualifications, equipment PQ’s and cleaning/shipping/process validations and validation maintenance

Responsibilities:

• Develop qualification/validation documents such as concept/strategy/plan, protocols, report and SOP’s whenever required, particularly in the area of final fill finish equipment, gmp mixers, autoclave, controlled temperature chambers (CTC’s) and various gmp direct systems
• Execute thermal mappings for CTC’s, load preparation and autoclave PQ runs and BI/TC placements
• Plan, execute Vaporised hydrogen peroxide (VHP) decontamination of fill finish equipment such as isolators and lyophiliser, manual cleaning development, engineering and water runs, aseptic media fill (AMF) and aseptic process simulation (APS) of fill finish systems (isolator, filling, stoppering, capping)
• Cleaning method development and verification for Grade A isolator including but not limited to cleaning approach and strategy, cleaning risk assessment, sampling rationale such as (cleanability , surface classification, MOC assessment, sampling locations, and hold time justification and calculation of residual acceptance limits (product residue, cleaning agent and carryover)
• Solve various challenges during equipment, cleaning, sterilization and process qualification/validation by proposing solutions to overcome them, conduct RCA, CAPA, change control in timely to meet project and operational schedule
• Coordinate with internal stakeholders (manufacturing DS and DP, facility and engineering, quality validations, operations and compliance as well as external stakeholders such as equipment vendors, rental providers and external testing labs for sample taking, preparation, submission and results
• Plan, deliver re-/qualification /validation activities and milestones according to project and production schedules
• Generate and maintain all qualification/validation activities in an inspection ready status ahead of any internal and external audits to ensure successful inspections ie. no critical observation related to qualification/validation activities – act as validation SME during regulatory audits/inspection
• Ensure qualification/validation related training requirement is met and up to date

Education, Behavioural Competencies And Skills:

• BSc/MSc in an engineering/scientific discipline (Bio/chemical/mechanical engineering/life science/biology/chemistry) with a minimum of 2-6 years relevant industry experience
• Knowledge/experience in Drug Product (DP)/fill and finish equipment qualification/validation activities, aseptic filling /process simulation (APS), Vaporized hydrogen peroxide (VHP) decontamination cycle development and PQ activities such as GMP mixers PQ, isolator PQ, smoke studies, filling, stoppering and capping machines PQ
• Experience in machinability evaluation, CCIT will be added advantages.
• Experience in project coordination, management of internal and external stakeholders in qualification related documents, protocols review, approvals
• Experience in authoring, executing, reviewing and approving qualification/validation protocols and report in support of facility /equipment commissioning, qualification/validation.
• Experience in raising exceptions/deviations during qualification/validation, perform investigations and utilise various root cause analysis tools in driving the closures in timely manner.
• Hands-on experience in technical execution of validation tasks associated with cleaning verification/validation, sterilization validation (ie autoclaves) and its sterile hold studies, controlled temperature chambers (CTC) like fridge and freezers, incubators using thermal mapping equipment like Kaye validators, Biological/chemical indicators handling and sample taking.
• Experience in supporting regulatory agency interactions such as regulatory submissions, response and submission questions, pre-approval/scheduled inspections, and observational response plans
• A thorough knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
• Well-organized and detail-oriented, with ability to effectively prioritize tasks with agility, eager to learn, interact and collaborate effectively with various stakeholders in a team environment and consistently demonstrate reliability and responsibility
• Must be a team player with good working ethics, initiative, diplomacy, positive influencing abilities and drive
• Good oral communication and demonstrable, exemplary writing skills
• Experience in clinical manufacturing validation is an advantage and not a must.