Associate Process Engineer

WuXi Biologics; Wuppertal; On-site; EUR 90,000 - 130,000; Full time

Job summary

WuXi Biologics in Germany is seeking a technical leader for the MFG19 engineering team (USP, DSP and MBS) to guide design, commissioning and the launch of a new biopharma manufacturing facility and products.

The role includes drafting GMP documents, ensuring equipment readiness, executing CAPAs, and coordinating maintenance and training. Strong English and German communication are required in a multinational setting.

Qualifications

• Leadership and technical oversight in a biopharma setting.
• Experience in GMP document generation and SOP drafting.
• Strong communication in English and German; ability to lead in a multinational team.

Responsibilities

• Provide technical leadership within MFG19 engineering (USP, DSP and MBS).
• Support design, commissioning and commercial launch of a new facility and products.
• Generate GMP documents including SOPs and provide equipment training.
• Lead investigations and CAPAs with cross-functional teams.
• Implement changes in TrackWise to support process fit and continuous improvement.
• Create work orders in Maximo and coordinate maintenance activities.
• Ensure EHS compliance for equipment modification and new facilities.
• Support equipment qualification deliveries during project phases including moves and commissioning.
• Participate in audits as the technical representative.
• Identify improvement potentials and implement related measures.

Skills

Leadership

CAPA & QA

GMP compliance

Project planning

Cross-functional collaboration

Equipment maintenance

Education

Degree in Biotechnology/Biopharmaceutical Engineering

Process Engineering background

Tools

Maximo

TrackWise

MS Office

SOP writing

Job description

• Provide technical leadership within MFG19 engineering (USP, DSP and MBS). Implement local and global expert input in a timely fashion with high quality.
• Support the design, commissioning and commercial launch of a new biopharma manufacturing facility and new products.
• Support and execute the generation of GMP documents including SOP.
• Provide equipment relevant technical training to engineering and manufacturing staffs.
• Have excellent inter-people skill and dedicated knowledge in biopharmaceutical process technology. Is responsible for dedicated process equipment readiness including related automation within given budget, time and quality aspects.
• Lead / participate in engineering investigations with cross-functions to ensure that root causes are analyzed completely and appropriate CAPAs are implemented.
• Implement change controls in TrackWise to support process fit, continuous improvement and CAPA’s within DS.
• Create work orders in Maximo, support equipment relevant maintenance and repair activities. Initiate, supervise and coordinate internal and external maintenance service of equipment.
• Ensure EHS compliance for equipment modification and new equipment / facilities.
• Provide technical support to equipment owner, production team, when new equipment is ordered, or old equipment is modified.
• Support equipment qualification deliverables during execution of project phase, including equipment move-in, commissioning, vendor SAT and WuXi IO&PQ / RQ.
• Participate inregulatory, client andinternal auditsinspectionsas the technical representative.
• Identify improvement potentials and implementation of related measures.

SAFETY CULTURE:

• Actively participate and support in HAZOPs and other risk assessments as required.
• Identify safety improvement opportunities and design, and implement steps to realize these opportunities.

COMPLIANCE and RFT

• Ensure equipment operates in a compliant manner and that all activities are conducted to meet cGMP regulations and Right First Time (RFT) principles..
• Routinely draft and revise standard operating procedures and training records, including the review of completed documentation.
• Prepare for and participate in GMP and Safety audits as required.

PERSON SPECIFICATION:

• .Ability to work on own initiative and be proactive.
• Results oriented, with the ability to manage multiple priorities in a short period of time.
• Excellent organizational and planning skills and strong attention to detail.
• Excellent interpersonal skills with the ability to work effectively with departments and staffs at all levels of the organization.
• Social competence, customer orientation and a good team player.

REQUIREMENTS:

• Must be able to show strong leadership skills with the ability to adapt to daily challenges of an engineering work environment while maintaining positive and productive attitude and fostering this attitude among colleagues.
• Experience in technical support, project planning and design of process equipment in the biopharmaceutical environment.
• Experienced user of MS Office as well as data bases.
• Excellent verbal and written communication and presentation skills in both German and English.
• Working within national and international teams.

EDUCATION (Indicate the requirement & preferred discipline):

• Degree completed vocational training, or equivalent qualification in Biotechnology, Biopharmaceutical Engineering, Pharmaceutical Engineering, Process Engineering, Mechanical Engineering, or a related technical field.
• Recent graduates as well as candidates with relevant technical training and practical experience are encouraged to apply.

ADDITIONAL POSITION SPECIFIC DUTIES/INFO (Not Covered in Generic Description of Job):

• Due to the start-up nature of the project, there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this job description.