- CAPA, Change Control experience.

Job Description

Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment. Ability to work on strict deadlines. Background in life science. Ability to interface with cross-functional teams. Detail oriented. Strong working knowledge of Quality System Regulations. Experience leading CAPA (Corrective and Preventive Action) activities. Ability to handle multiple projects concurrently. Well-developed communication skills, both verbal and written.. Years of Experience: 6 - 9 Years

Primary responsibilities include computerized system validation and computerized equipment qualification.

• Looking for support filling a new onsite role in Swiftwater, PA. Target start is the first week of March. Here are the key details for recruiting:
• Duration: 12-18 months
• Location: Onsite in Swiftwater; candidates willing to relocate at their own expense are acceptable.
• Schedule: 8 4 or 9 5

Education: Bachelors required; master's or PhD also fine (PhD not considered overqualified).

• Bachelor's Degree/Undergraduate Degree in engineering or technical discipline.
• Master Degree preferred.
• Years of Experience: 6 - 9 Must have experience:
• Proven track record in computer validation
• Experience with MES & ERP (SAP)
• Biopharmaceutical experience
• Experience in FDA regulated industries
• Nice to have: Strong Microsoft (Excel, Word, Outlook) skills
• Work environment: Office setting, team of 4, free parking
• Interview process: Zoom or possibly in person