Description:

12 months due to GROW rotation of staff member

Need 5 years experience in a manufacturing operations role (similar) coming from (in order of preference):

1 - Aseptic/sterile

2 - API

3 - Biologics/ bio-pharma

Strong communicator, organisational skills, adhering to deadlines

LEAN would be advantageous

JOB DESCRIPTION OF THE MANUFACTURING PROCESS SPECIALIST:

Duties and Responsibilities

• As a core member of the business unit the Manufacturing Process Specialist is responsible for providing technical support to the business unit in ensuring efficient manufacturing while ensuring compliance with GMP, EHS standards at all times.

Responsibilities includes:

• Development of new and revised manufacturing and cleaning recipes in line with Master Batch book requirements.
• Development of and subsequent reporting on metrics relating the overall end to end performance of the business unit including the preparation of scorecards, dashboard and data for management review.
• Management of investigations (including customer complaints, EHS incidents, NCPs etc.) to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions.
• Management of the manufacturing related aspects of the Change Control system in line with site procedures.
• To participate in HAZOP studies so that potential problems are identified and designed out of processes.
• Identification of opportunities for improvement within the manufacturing process through trend analysis and continuous review of all operations (e.g. completion of Self Inspections/ Internal Audits/process Optimization).
• Partnering with business unit personnel in the proactive identification of innovative solutions to problems.
• Develop re processing /rework strategies, test methods and protocols.
• Attendance at operations meetings as required in support of the Business Units.
• This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.

Job Function Competencies:

• The Competency of Personnel to perform their assigned functions is acquired by appropriate Qualifications, Education, Training and Experience, (Knowledge & Skill) or any combination of these.

Minimum Requirements

• The position of Manufacturing Process Specialist requires a third-level qualification in the relevant field