Job Description

Leading cross-functional teams to plan, facilitate, and execute all phases of process engineering and validation for solid dosage, liquids, sterile and devices including cleaning, processes,  equipment & facilitates

Provide technical and regulatory expertise to a wide range of life science and food industry clients including: Medical Device Manufacturers, Pharmaceutical Manufacturers, Virtual Companies, Industry Suppliers and Biotechnology Companies.

Function as a Subject Matter Expert with multiple clients performing cleaning and passivation, including trouble shooting existing processes and developing new processes.  Responsibilities included acting as the SME in response to FDA and EU/MHRA audits directly reviewing cleaning approaches in multi-API facilities including potent compounds.

·         Provide management oversight and technical expertise to the Life Sciences Practice 

·         Provide project management in support of  Life Science client engagements.

·         Develop cleaning validation methodologies and strategy 

·         Conduct technical review and revision of client Standard Operating Procedures for Laboratory Information Management Systems (LIMS).

·         Provide project and process trouble shooting in support of OSD and sterile processes for CP clients.

·         Collaborate with  Engineering and Architecture design teams on cGMP approaches to optimize designs for efficient validation and to ensure cGMP compliance.

·         Provide regulatory guidance and approach to medical device manufacturers in support of process changes, passivation, cleaning and remediation activities.

Qualifications

Bachelors Degree

5+ years related exp.

Ability to travel

Additional Information

Please attach a WORD resume to your on-line application.

This is a consulting position NOT FT

1099 OR W2.  NO!  AGENCIES PLEASE...

All your information will be kept confidential according to EEO guidelines.