Senior Production Associate MBS

The Senior Production Associate Media Buffer Supply reports to the Shift Lead and plays a central role in building up the department during the ramp-up phase as well as in regular production by supporting the team to consistently achieve specific Key Performance Indicators (KPIs). ActingasthedeputyfortheShift Lead intheirabsenceparticularlywithregardtotechnicalinstructionsandthecoordinationofoperationalprocesses(nodisciplinarymanagementresponsibility).

Responsibilities

• Supports the implementation of training and safety programs and helps ensure employees are familiar with and adhere to company SOPs policies cGMPs and applicable safety and regulatory requirements.
• The Senior Production Associate provides support in the preparation planning and execution of equipment setups personnel allocation production activities and in the preparation and participation in manufacturing meetings.
• Supports technical leadership in the production area; supports supervision and conducts handson training for manufacturing personnel (37 employees).
• Participate in projects and activities which support manufacturing goals.
• Drafts GMP documents (e.g. SOPs MBRs URS FAT SAT CC deviations); final preparation and approval are performed by the responsible function/department.
• Coordinate activities with other operational groups (quality facilities materials etc.) to ensure schedule adherence.
• Ensure that all manufacturingrelated activities are completed accurately and within the allotted time frames.
• In the event of disruptions to normal operations crossdepartmental activities are to be performed.
• Shift work weekend and public holiday availability and on-call duty may be required.
• Responsible for technical guidance of employees to ensure the proper level of performance and behavior.
• Assist with organizational audits to assess the current and future needs of the organization.
• Ability to solve manufacturing problems and deal with a variety of situations where critical problem solving is required.
• Attendance at meetings as required or in the absence of the shift supervisor.

The employee is the deputy of the position Shift Lead for the following responsibility.

• Acting as the deputy for reviewing corresponding Manufacturing Documentation like SOP Production Batch Records Methods/Recipes etc.
• Verifying that all GMP requirements are being followed within manufacturing.

The deputy for this employee is the Production Associate for the following responsibilities.

• Technical supervision of routine tasks.
• Verifying that all GMP requirements are being followed.

Education Background

• An apprenticeship as a Chemikant/Pharmakant or CTA/BTA is advantageous.
• A degree in natural sciences or engineering (diploma bachelors or masters degree) or a related professional qualification is advantageous.

Experience

• More than 3 years of experience in biopharmaceutical manufacturing with extensive hands-on experience is required.
• Experience with process control systems (e.g. ABB DeltaV).
• Experience in dealing with audits and a solid understanding of quality systems related to deviations investigations CAPA and change control would be advantageous.

Knowledge

• Must be quality-focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
• Must be EHS-focused with knowledge and understanding of EHS regulations and how they apply to manufacturing environments.
• Language skills: Good knowledge of German is required. English skills at a minimum of B2 level are desirable.

Behavioural Competencies

• Excellent verbal and written communication and presentation skills.
• Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
• Ability to work on ones own initiative and be proactive.
• Ability to lead smaller groups of employees (3-7) to accomplish production activities.
• Results oriented with the ability to manage multiple priorities in a short period of time.

WuXi Biologics is an equal opportunities employer