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Upstream Process Shift Leader (m/w/d)

Wir suchen für unseren Kunden WuXi Biologics am Standort Wuppertal (auf dem Bayer-Gelände) Upstream Process Shift Leaders (m/w/d).

WuXi Biologics, eines der drei weltweit größten Unternehmen mit einer führenden Open-Access-Technologieplattform für die Entdeckung, Entwicklung und Herstellung von Biologika. Zur Ergänzung der bestehenden Produktionskapazitäten übernimmt WuXi Biologics den Betrieb einiger Produktionsanlagen der Bayer AG in Leverkusen und in Wuppertal für die Herstellung von Arzneimittelendprodukten.

Da es sich bei WuXi um einen international tätigen Konzern handelt und gute Englischkenntnisse Voraussetzung sind, lesen Sie bitte nachfolgend die Stellenausschreibung auf Englisch:

Summary of Role
In this role you will report to the Manufacturing UPS/DPS Director and will initially be responsible for supporting all operational readiness activities to ensure the facility design meets end user requirements. Upon successful commencement of commercial operations, the role will evolve to leading a team of highly trained professionals in the manufacture of biological products in adherence to the highest standards of quality and regulatory compliance. As a Shift leader you will be responsible for the recruitment, development and retention of the team in order to consistenty deliver on the specific KPI’s and also to meet with the expectations of our customers.

Principle Job Responsibilities:

  • Key member of Manufacturing leadership team and will play an important role in the execution of the business plans, ensuring cross functional collaboration and leadership execution
  • Responsible for the operator assigned to the shift on an ongoing basis and shift personnel in Maintenance, TS, IPC etc. while they are on shift outside day hours
  • Supervision on a day to day basis, training and communications, assignment and prioritization of work, delivery of objectives, performance management including development of direct reports, resolution and escalation of grievances and disciplinary issues
  • Responsible for emergency procedures, safety systems, safety performance, communication and behaviours on the shift
  • Performs safety audits and walk downs as required and also participates in HAZOPs and reviews documentation as required
  • Liaises with statutory agencies when required
  • Reports and leads the investigation of safety or environmental incidents on the shift and records, reports and resolves/escalates unsafe conditions or near misses that are observed
  • Acts as Authoriser for the Permit to Work in manufacturing during normal day shifts and in all areas across site in the out of hours
  • Ensures that the plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements as required
  • Provide technical support to the plants as required
  • Reports and investigates batch deviations or quality issues on the shift and escalate issues promptly
  • Raises change controls and emergency change controls and oversees the review of completed documentation and is responsible for RFT on shift
  • Conducts any checks, inspections or audits necessary and is also responsible for housekeeping and audit preparations in assigned areas
  • Ensures that relevant risk assessments are completed and manages training for their shift team and own the respective training plan
  • Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times
  • Where necessary assist in Facility and Equipment start up and Validation activities
  • Manages day to day operations on shift. Ensures functional area targets, objectives and performance criteria are understood and met.
  • Aligns shift activities with changing business needs and prioritizes tasks and assigns resources accordingly
  • Makes technical decisions and escalates issues promptly and also works cross-functionally and cross-shifts to resolve issues and drive improvements
  • Responsible for schedule adherence metric on shift; drives performance to ensure throughput and changeover targets are met
  • Supports technical transfer activities., provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products
  • Write, review, revise and approve of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instruction
  • Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.)
  • Maintain the designated place of work in a clean and tidy state at all times during production activities
  • Flexibility to take on additional tasks and responsibilities at the discretion of the Manufacturing Director
  • Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values, local site shared commitments/behaviours

Required Qualifications and Experience:

  • Ideally, experienced in supporting a manufacturing department and building a team in a ‘greenfield’ context of similar size and scale
  • Minimum of 8 years’ supervisory/leadership experience in the pharmaceutical/biopharma industry in a direct manufacturing support role
  • Extensive experience in leading teams, supporting the continued development of employees, motivating and enaging them to achieve their potential
  • Expert experience in dealing with and resolving employee grievances and maintaining a positive and progressive work environment/culture at all times
  • In-depth knowledge of relevant cGMP, safety and environmental regulations
  • Expert knowledge and experience of the manufactuting equipment and associated processes
  • Excellent knowledge of the documentation standards and protocols in a pharmaceutical/biopharma manufacturing environment
  • Minimum of a degree in a science, chemical engineering or related subject
  • Strong leadership with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports
  • 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 own initiative and be proactive
  • Results oriented, with the ability to manage multiple priorities in a short period of time
  • Excellent organisational and planning skills and strong attention to detail
  • Travel requirements, shift work etc. if applicable

Wir freuen uns auf Sie!
Unser Kunde bietet Ihnen ein leistungsbezogenes Einkommen und sehr gute Möglichkeiten zur fachlichen und persönlichen Weiterqualifizierung. Wenn Sie sich in dieser Stellenbeschreibung wiederfinden, bewerben Sie sich bitte per E-Mail mit Ihren vollständigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse gerne in Englisch).

Ihre Ansprechpartnerin:
HR-Office GmbH
Nivia Moritz
Kohlfurther Straße 65
42349 Wuppertal
Tel. +49 (0) 202 942295 – 95
www.hr-office.eu
nivia.moritz@hr-office.eu

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Telefon

+49 (0) 202 942295 – 95

Fax

+49 (0) 202 942295 – 96

Mail

info@hr-office.eu

Adresse

HR-Office GmbH
Kohlfurther Straße 65
42349 Wuppertal