Not specified; competitive salary offered; benefit...
100% on-site
5+ years pharmaceutical validation experience
Bachelor's degree in engineering or related field
Expert knowledge of 21 cfr part 11 and data integrity
The Sr. Validations Specialist position at Alcami, located in Morrisville, NC, is focused on ensuring compliance with pharmaceutical regulations through validation processes for equipment and GxP computerized systems. The role requires a strong background in validation documentation and cGMP compliance, with an emphasis on collaboration and problem-solving
Job Summary
The Sr. Validations Specialist is accountable for driving results by supporting the general pharmaceutical validation of equipment and GxP computerized systems.
The role requires acting as a certified trainer and subject matter expert during audits and inspections while ensuring compliance with cGMP standards.
Alcami offers a competitive salary, exceptional benefits package including medical, dental, vision, and 401(k) with immediate vesting.
Matching Summary
Match Score: 85
The Sr. Validations Specialist position at Alcami, located in Morrisville, NC, is focused on ensuring compliance with pharmaceutical regulations through validation processes for equipment and GxP computerized systems. The role requires a strong background in validation documentation and cGMP compliance, with an emphasis on collaboration and problem-solving.
Salary
Not specified; Competitive salary offered; Benefits include medical, dental, vision, prescription coverage, life, LTD, STD, 401(k) with match, and tuition reimbursement
Skills & Requirements
Must-have
5+ years pharmaceutical validation experience
Bachelor's degree in Engineering or related field
Expert knowledge of 21 CFR Part 11 and Data Integrity
Experience with facility, utility, and equipment qualification
Strong mechanical skills for production equipment
Nice-to-have
Knowledge of Kaye AVS software
Proficiency with Pro Cal tool
Ability to train and mentor others
Experience serving as subject matter expert during audits
Strong communication skills for cross-functional collaboration
Key Requirements
Bachelor's Degree in Engineering, Chemistry, Biology, or related field
Minimum 5 years of related validation experience
US work authorization required for on-site position in Morrisville, NC