Lead Commissioning Engineer

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PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.  We are seeking experienced Non-GxP Commissioning Engineers for opportunities in Denmark.

Objectives of this Role:

· Prepare the commissioning strategy and guidance via the review, writing, and executing commissioning activities.
· Provide team leadership and co-ordination
· Manage stakeholders and project scope and execution
· Provide the coordination and execution of commissioning and qualification activities including writing protocols, executing, review of documentation that support research laboratory spaces.
· Execution of commissioning plans and commissioning protocols for projects that impact facility, processes, equipment, cleaning, and software systems.
· Experience writing and preparing commissioning protocols such as URS, FS, IQ, OQ, PQ, TM, Commissioning Plan, Q/VSR and execute qualification and revise as needed.
· Assist in troubleshooting problems arising from equipment/system failures.
· Ensure continuous commissioning maintenance for equipment, facility and process through the change control program.
· Analyze commissioning data, prepare reports, and make recommendations for changes and or/improvements.
· Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or commissioning activity.
· Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.

Skills and Qualifications:

· Bachelor's degree in Engineering or similar technical field
· 5 to 10 years of Relevant new facilities/equipment start-up, commissioning & qualification, FAT experience in Pharmaceutical/biotech and/or Medical Device industry
· Strong experience in team lead role
· Strong Hands on commissioning and qualification experience with significant process equipment commissioning
· Fluency in Danish is a plus
· Must be able to communicate clearly (written, verbal) 

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


Lead Commissioning Engineer

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.  We are seeking experienced Non-GxP Commissioning Engineers for opportunities in Denmark.

Objectives of this Role:

· Prepare the commissioning strategy and guidance via the review, writing, and executing commissioning activities.
· Provide team leadership and co-ordination
· Manage stakeholders and project scope and execution
· Provide the coordination and execution of commissioning and qualification activities including writing protocols, executing, review of documentation that support research laboratory spaces.
· Execution of commissioning plans and commissioning protocols for projects that impact facility, processes, equipment, cleaning, and software systems.
· Experience writing and preparing commissioning protocols such as URS, FS, IQ, OQ, PQ, TM, Commissioning Plan, Q/VSR and execute qualification and revise as needed.
· Assist in troubleshooting problems arising from equipment/system failures.
· Ensure continuous commissioning maintenance for equipment, facility and process through the change control program.
· Analyze commissioning data, prepare reports, and make recommendations for changes and or/improvements.
· Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or commissioning activity.
· Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.

Skills and Qualifications:

· Bachelor's degree in Engineering or similar technical field
· 5 to 10 years of Relevant new facilities/equipment start-up, commissioning & qualification, FAT experience in Pharmaceutical/biotech and/or Medical Device industry
· Strong experience in team lead role
· Strong Hands on commissioning and qualification experience with significant process equipment commissioning
· Fluency in Danish is a plus
· Must be able to communicate clearly (written, verbal) 

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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