Reports to : Senior Manager, Technical Services & Validation
Snr/Technical Operations Engineer (DP)
Reports to : Senior Manager, Technical Services & Validation
Objectives:
Act as tech transfer lead for process technology transfers from R&D, CMC or external collaborators to and from GMP clinical manufacturing of different modalities and platforms to meet tech transfer objectives
Provide supports in biologics and vaccine plant start up of a start-of-the-art fill&finish manufacturing facility and operation by providing technical/SME input, audit, investigation and CAPA
Collaborate closely with key stakeholders within GMP clinical manufacturing such as Operations (Drug Product), Engineering, Validation, QA in meeting program /tech transfer schedule
Support as process/area owner during manufacturing scale up, optimization of drug product formulation and filling facility readiness
Provide external contract manufacturing oversight in technical operations to achieve project deliverables and timeline
Responsibilities:
Lead/support tech transfer of process/product (vaccine preferred) with different modalities/platform from internal stakeholders and to/from external manufacturing partners in terms of tech-ops support such as deviations, change control and process input
Experience with drug product formulation, aseptic filling of various formats such as liquid and lyophilized (freeze-dried), stoppering, capping, labelling and packaging, CCIT
Provide external manufacturing support as part of tech transfer oversight
Work and coordinate with different sub teams during tech transfer of drug product to ensure their timely involvement and alignment to the strategy and successful completion according to tech transfer schedule and deliverables.
Act as Subject Matter Expert (SME) in fill & finish equipment, including but not limited to grade A isolator system with glove technology, VHP decontamination/ sterilistation, manual/cleaning validation/verification, machinability evaluation
Act as SME in supporting users for water run, engineering run and media runs and aseptic medial fill and process simulation.
Perform product/process root cause analysis for complex deviations and investigations using established problem-solving tools
Mentoring operations crew in process and equipment knowledge and know-how to operate equipment as per design intent and troubleshoot operational issues
Provide impact assessment and support to change control and deviations of GMP runs during clinical manufacturing
Perform risk assessment related to process, engineering and safety (ie FMEA)
Perform gap/risk assessment in terms of raw materials and consumables
Support process/equipment procurement specification review, qualification/validation activities
Support standard operating procedures (SOP) generation for process/equipment
Support Audit as technology transfer SME where required
Act as a training/document coordinator for the department
Support cross-functional team such as validation related activities if required
Act as a delegate to the Supervisors/Managers and conduct team activities in their absence
Education, Behavioural Competencies And Skills:
BSc/MSc in an engineering/scientific discipline (Bio/chemical engineering/mechanical/life science/biology/chemistry) with 4-8 years relevant industry experience
Biological technology transfer experience required in various modalities such as viral vector vaccines, biologics, mRNA process and LNP formulation
Experience/knowledge of cGMP practices as applicable to upstream/downstream vaccine manufacturing processes, process development is desirable
A thorough knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) and knowledge in guidelines and requirements from health authorities/regulatory bodies
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 with problem solving and statistical tools will be an advantage
