Sr Validation Scientist

Actavis ? creating value in pharmaceuticals

 

The Actavis Group is a leading player in the development, manufacture and sale of high-quality generic pharmaceuticals. The addition of Alpharma?s Human Generics business in late 2005 positions the Company as the fourth largest generic pharmaceutical company in the world, with 10,000 employees in 32 countries. Founded in 1956, the Group operates across five continents. Its headquarters are in Iceland.

 

Actavis is a fast growing company, headquartered in Iceland with modern development and manufacturing facilities in Europe, the US and Asia and an extensive sales and marketing network in five continents.  Actavis Group is now one of the five leading generic pharmaceutical companies in the world, with 10,000 employees in over 30 countries.  The Group offers one of the broadest portfolios in the generics sector and a wide variety of products in development and registration, enabling it to provide its customers with a wide range of affordable high quality pharmaceuticals. 

Actavis is looking for individuals who are ambitious, pro-active and flexible enough to seize the opportunities around them. At Actavis we foster teamwork and value our resources, working efficiently to provide first class customer care.

 

Our U.S. Generics Division is currently searching for a Sr. Validation Scientist to work in

Elizabeth, NJ who will lead a team that develops strategies, protocols, and final reports for product-specific projects; inclusive of Cleaning Validation, Process Validation, Process Optimization or Scale-Up, troubleshooting, etc.

 

Responsibilities:

 

- Act as a team leader for 3-4 Technical Service scientists; coordinate priorities and ensure commitments are completed on time in support of commercial products.

- Support wet granulated product line.

- Design protocols, monitor studies, and write final reports for product related projects such as Cleaning Validation, Process Validation, and / or Process Optimization.

- Monitor commercial production for assigned products and investigate process related issues. Write / investigate product related deviations in support of root cause / corrective action.

- Complete required Annual Product Reviews (APRs).

- Support new product development in the development of product master formulas / processes.

- As needed, execute equipment qualifications (IQ/OQ/PQ) for assigned equipment in Production / R+D.

- Must be willing to support team projects with weekend / off-shift coverage, as needed.

 

Requirements:

- BS/BA Required

- 5-10 years of experience in Process Validation, Cleaning Validation and equipment Qualification.

- Must have supervisory experience.

- Strong written and oral communication skills.  Capable of writing validation protocols and technical reports to support study objectives.  Capable of presenting validation issues and results to management.

- Good interpersonal skills.  Capable of interacting with Laboratory, Quality, Development, Manufacturing and Engineering personnel for the coordination of validation studies and resolution of issues.

- Proficient in software relating to the writing of validation documentation and data analysis/reporting.

- Strong understanding of manufacturing methods, equipment and controls for the production of solid oral dosage forms.

- Knowledgeable in current Good Manufacturing Practices, FDA guidelines and DEA regulations.

- Good problem solving ability and analytical thinking; capable of independent work

- Proficient in Cleaning and/or Process Validation principles.

 

We offer a competitive salary & a comprehensive benefits package to all eligible employees. Please e-mail your resume, cover letter & salary requirements to GGrossinger@actavis.com

(Att: Sr. Val Sci - MB).

 We are an Equal Opportunity Employer and appreciate diversity in our workforce.