Process Owner (w/m/d) On Site

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Job Description

Job Responsibilties:

• Take care of the availability of up to date process guidelines (e.g SOPs, MBRs, forms, ,..) in order to assure a regulation compliant production of plasmatic and recombinant products in Pharmaceutical Production Site Lange Alle 24B (LA24B).

• Take care of a continued adjustment and improvement of process guidelines/ descriptions in accordance with current regulations (such as GxP, EHS), aligned with clients and partner-departments.

• Main responsibility for production processes of LA24B - floor E1 (Filling, Lyophilization & Crimping)

• Representative or lead of LA24B unit projects

• Represent the site/ processes during authority inspections, including inspection- and visitor- tours.

• Main responsibility for production processes of LA24B - floor E1 (Filling, Lyophilization & Crimping)

Your Tasks in this position:

• Owner & definition of the subject specific content in process descriptions (SOPs, MBRs, forms, …) and for recipes, if applicable, in order to enable the production of plasmatic and recombinant products in the site LA24B.

• Reviewing complaints/ reports, performing change evaluations for equipment and processes and supporting investigations of deviations which are in the related owner’s responsibility. Decision-making for actions to be taken, based on investigation results.

  • Apply lean management/ Six Sigma tools if needed

  • Work close with the CAPA team to assure adequate investigations and support timely close of CAPAs to assure customer supply

• Participation in projects/ initiatives/ problem solving

  • Support the implementation of new products/ processes within the department

  • Partner with other functions to optimize results and product value streams

  • Identify and implement improvements leading to reduced lead-time, cost reduction, complexity reduction and increased efficiency of own activities, processes and equipment, and assuring that product quality is not negatively affected by the changes/ improvements

• Expert opinion and approval of plans and reports needed for validation of production equipment and processes which are in the owner’s responsibility

• Implementation and compliance with the relevant GMP, Quality and EHS requirements

  • Assure inspection readiness against relevant guidelines and requirements (GMP, EHS, …)

  • Report accidents or potentially dangerous situations and take corrective and/ or preventive actions

  • Support safety standards and EHS measures

• Gemba Walks and supervision of production and processes on demand and in line with department targets

What you bring to Takeda:

• Autonomous execution, assertiveness, ability to work under pressure (regarding criticality in time and scope), accurateness, reliable, diligently, enthusiastic and keen for working focused on solution and result, versatility

• Distinct social skills, team oriented, skilled in organizing and coordinating of tasks, logical joined-up thinking, ability to present complex coherences as simple and easy comprehensible in order to facilitate an effective speech communication

• Technical understanding, EDV-skilled (MS-Office applications), quality awareness, hygiene awareness,

• Skilled in German and English language (in speech and writing)

• Several years of professional experience in a pharmaceutical or food company or a process-oriented company

• High business acumen to achieve predefined company targets

• Be able to balance customer supply, patient safety, financial targets and efficiency

The position is limited until 31.03.2027 with the possibility of extension.

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 3.307,50 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

• Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten

• Work @ home depending on the position / department

• Comprehensive training programs

• In-house job rotation program

• In-house Canteen with discounts or meal vouchers

• Works council (events, festivals, shopping vouchers, etc.)

• Employee Referral Program

• Employee Recognition Program

• Takeda Resource Groups

• Medical checkups

• Free vaccination program

• Fitness Center

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