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 Commissioning Engineers (BMS) for opportunities in Denmark.
Objectives of this Role:
· Review commissioning and qualification documentations for accuracy, technical soundness and compliance to both site and regulatory guidelines. · Projects may include commissioning new facilities/equipment’s and automation systems.
- Knowledge or experience of single use systems would be of interest
- Knowledge or experience of fill finish systems would be of interest
- Knowledge or experience of clean room qualification and commissioning would be of interest · Provide support to CVQ team for user requirement and functional specifications. · Provide support to site Technical Services management through commissioning and qualification activities across the site. · Assist in generation and execution of commissioning and qualification documentation. · Review documentation and drawings to ensure that documents meet quality and are in full compliance with regulations and standards. · Support commissioning team to investigate, troubleshoot problems and determine possible solutions. · Support execution of commissioning plans and protocols such as URS, FS, IQ, OQ, PQ, TM, Commissioning Plan, Q/VSR and revise as needed.
Skills and Qualifications:
· Bachelor's degree in Engineering or similar technical field · Experience in commissioning and qualification activities is required. · 1 to 4 years of commissioning experience in Pharmaceutical/biotech is strongly preferred · Experience in commissioning and qualification of biopharmaceutical process equipment is strongly preferred · Experience or working knowledge of GMP requirements is strongly preferred · Experience with automation systems is a plus · Must be able to communicate clearly (written, verbal) Why PharmEng Technology? Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.