The Senior Production Associate 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). Acting as the deputy for the Shift Lead in their absence, particularly with regard to technical instructions and the coordination of operational processes (no disciplinary management responsibility).
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 hands‑on training for manufacturing personnel (3–7 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 manufacturing‑related activities are completed accurately and within the allotted time frames.
- In the event of disruptions to normal operations, cross‑departmental 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, bachelor's, or master's 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 one’s 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
