A pharmaceutical company in Fall River, MA is seeking a Manufacturing Validation Engineer to oversee the creation and revision of GMP documentation. The role requires effective cross-functional collaboration to ensure compliance and operational success, alongside responsibilities such as developing metrics and implementing continuous improvements. Candidates should have relevant experience in validation and familiarity with SOPs. This is a full-time position with options for professional growth.
Qualifications
Ability to prepare qualification and validation documents.
Experience writing, revising and creating cGMP records and SOPs.
Knowledge in handling deviation, CAPA, change control.
Responsibilities
Develop metrics and work with personnel to achieve targets.
Create training materials and track periodic reviews.
Lead root cause investigations and develop solutions.
Skills
Excellent communication skills
Drive and sense of urgency
Excellent computer skills
Solid organizational and time management skills
Ability to work as a self-starter
Knowledge of pharmaceutical manufacturing
Education
Associate’s degree with 4-6 years knowledge of GMP documentation
Bachelor’s degree in science, biochemistry, pharmaceutical engineering
Master’s degree in Pharmaceutical Engineering or related field
Tools
Microsoft Office Suite
SAP business system
Job description
A pharmaceutical company in Fall River, MA is seeking a Manufacturing Validation Engineer to oversee the creation and revision of GMP documentation. The role requires effective cross-functional collaboration to ensure compliance and operational success, alongside responsibilities such as developing metrics and implementing continuous improvements. Candidates should have relevant experience in validation and familiarity with SOPs. This is a full-time position with options for professional growth.