Pharma Drug Product Technical Services Specialist

PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion, and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Pharma Drug Product Technical Services Specialist to join our team.

Job Summary:

This role provides technical subject matter expertise to External Supply Operating Unit, contributing directly to the lifecycle management of solid dose and sterile injectable Drug Products produced by contract manufacturers (CMOs). Manages process optimization and/or in situ change projects; investigates and resolves product or process failures that impact product quality.

The scope of the current open position 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 3rd party manufacturing locations (CMO).

The Tech Services Specialist or Engineer uses their own expertise as well as leveraging subject matter experts from across the organization to develop and deliver effective solutions vs identified challenges; interacts closely with Operations, Quality, Supply Chain functions, as well as Regulatory Affairs and the CMOs themselves.

Key Responsibilities:

• 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 the definition of the change, participation in the business case development, through planning, endorsements, execution, and closing.
• Uses the organization's established processes for the proactive optimization of product–process performance (also known as Process Robustness).
• Partners with all other functions responsible for the progress of the investigation, change or optimization project, typically 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 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.
• Takes ownership of administrative activities related to the project such as action/issue item tracking and follow-up, generation of project meeting agendas and minutes, coordination, and facilitation of focused working sessions involving internal and external team members and stakeholders.

Qualifications:

• 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 of 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 working in a third-party manufacturing environment (either as a contract giver or acceptor) is beneficial, but not essential
• An understanding of the Pharma regulatory environment, while not essential, would be advantageous.
• Experience working remotely in a matrixed & virtual environment.