Looking for an exciting job in Puurs? Do you have a degree in a Chemistry, Bioscience or Engineering discipline? Do you have a strong theoretical and practical knowledge of pharmaceutical manufacturing unit processes for both solid dose and sterile injectable dosage forms, with a minimum of 10 years' experience working directly within Drug Product process development or manufacturing, ideally in a technical support / troubleshooting type role? Don't hesitate to contact us!
The scope of the current open position at our client includes (a) Drug Product technical investigations, solution development & implementation; (b) technical change management and (c) proactive process optimization projects resulting in improved product & process performance.
The sites where the products are manufactured are external sites i.e. a 3rd party manufacturing location (CMO).
The Tech Services Specialist or Engineer uses their own expertise as well as leveraging subject matter experts from across our client to develop and deliver effective solutions vs identified challenges; interacts closely with our clients Operations department, Quality, Supply Chain functions in particular, as well as Regulatory Affairs and the CMOs themselves.
- Resolves technical problems effectively and efficiently. Starts with clear and concise Problem Statements and ends with the planned implementation of clearly defined & effective CAPA. Proficient in DMAIC and other six-sigma methodologies.
- Can coach others on problem solving techniques and methods
- Works independently to meet stakeholder needs and expectations; may involve the leadership of a matrix team.
- Maintains oversight on the budget during the change period; manages project risks i.e. leads the development of risk assessment and mitigations with the project team.
- Leads technical change, from definition of the change, participation in the business case development, through planning, endorsements, execution and closing.
- Uses our clients established processes for the proactive optimization of product - process performance (also known as Process Robustness).
- Partners with all other functions responsible for progress of the investigation, change or optimization project, typically Pfizer Quality, External Supply Operations, Supply Chain, Artwork team, Regulatory, CMO.
- Good communicator who reports clearly on progress and at a frequency required by stakeholders; can clearly articulate obstacles and challenges encountered, requiring wider team or senior management direct support.Communication is typically through our clients VSOT model (Virtual Site Operations Team).
- Specific to longer duration projects e.g. process optimization or technical change: the establishment and management of routine team meetings to facilitate plan updates, decision-making, problem solving, escalations e.g. resourcing gaps, mitigations vs non-adherence to plan.
- Minimum of a Degree in a Chemistry, Bioscience or Engineering discipline.
- Strong theoretical and practical knowledge of pharmaceutical manufacturing unit processes for both solid dose and sterile injectable dosage forms, with a minimum of 10 years' experience working directly within Drug Product process development or manufacturing, ideally in a technical support / troubleshooting type role.
- Project management training and minimum 3 years' experience acting as the leader of matrix teams handling complex technical projects. Ability to demonstrate successful execution of technical change projects on schedule and to budget.
- Experience of working in a third-party manufacturing environment (either as contract giver or acceptor) is beneficial, but not essential.
- An understanding of the Pharma regulatory environment, while not essential, would be advantageous.
- Experience of working remotely in a matrixed & virtual environment.
- Excellent written and verbal communication skills. Ability to articulate a problem and communicate effectively with team members and stakeholders at all levels. Intuitive and focused on achieving results.
- Well-developed interpersonal skills (leadership, communication, integrity, team orientation, flexibility and creativity)
- Existing right to work in Europe required.
- A balanced salary package based on your capabilities and experience
Vacancy number : 18196