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Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Summary
This position leads the manufacturing support area to ensure process and compliance support to the operational activities for the production of recombinant products
This position supports project teams in the design, commissioning, qualification and validation of new production lines for recombinant products
This position supports New Product Introduction for recombinant products
Technical Responsibilities
Operational duties:
Is responsible for the manufacturing support of daily operations of Upstream and Downstream processes in manufacturing suites
Lead and develop Manufacturing support team in order to ensure process areas are running robustly and efficiently, and ensuring appropriate succession planning
Participates in defining robust process parameters during routine manufacturing campaigns
Build cross functional teams and interact with other support functions such as Quality Assurance, Quality Control, Manufacturing Science and Technology, Engineering, Validation, and other relevant functional areas
Project duties:
Works closely with the PMO, Engineering, Quality and Business Technology to support the design, procurement and commissioning of production equipment and automation systems in accordance with process requirements and compliance.
Participates in Technology Transfer and operational readiness activities to implement new production processes and new lines.
Supports CVQ, PQ, Process Validation execution.
Quality
Ensures implementation of and adherence to current GMP rules, Quality policies, procedures and instructions for their area of responsibility.
Ensures contribution of their unit to continuous quality improvement initiatives and deviation reporting and follow-up.
EHSS
Ensures implementation of and adherence to EHSS legal requirements, rules, policies, procedures and instructions for their area of responsibility.
Ensures contribution of their organizational unit to EHSS initiatives and issues as well as near miss reporting and follow-up.
Leadership
Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
Takes personal accountability for their presence, performance, and productivity for the achievement of defined objectives.
Thinks and acts with a customer-centric approach.
Is intellectually curious and embraces Practical Process Improvement (continuous improvement).
Relentlessly attracts and develops talent to deliver exceptional performance and achieve their full potential.
Removes barriers to success and enables a work environment where colleagues can be their best self and motivated to excel.
Enables strategic focus by setting the right objectives prioritizing work and resources across the team and organization to improve impact.
Position Qualifications
Education
Bachelor/Master in Chemistry / Biochemistry / Biology / Food Science
Language: English, German is helpful
Experience & Competencies
>10 years successful experience in pharmaceuticals operations in a GMP relevant environment
the function requires experience in biotech or pharma processes, either in sterile processes, USP, DSP, solution preparation, single use, CIP/SIP processes
Good knowledge and competence in the field of automated processes
Experience in leading teams
Additional Requirements
Occasional work on weekend, public holiday and during night according to need of production planning
On-call duties is expected according to production planning. This includes work on weekend, public holiday and during night
Benefits
We offer driven remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Seniority level Seniority level Not Applicable
Employment type Employment type Full-time
Job function Job function Production, Supply Chain, and Manufacturing
Industries Pharmaceutical Manufacturing and Biotechnology Research
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