Senior Engineer – cGMP & Validation

About the role

Kelly Services is hiring a Senior Engineer to support a leading pharmaceutical/biotech client in Juncos, Puerto Rico. The role is a 6‑month contract focused on cGMP engineering practices, technical documentation and validation activities for production facilities.

Key responsibilities

• Develop and maintain technical documents, including SOPs and validation protocols.
• Apply cGMP procedures and engineering best practices to production equipment and processes.
• Manage QRAES, Change Control, non‑conformance, CAPA and validation activities.
• Utilize Maximo for equipment management and generate/submit purchase orders.
• Coordinate vendor visits and ensure compliance with safety and quality standards.
• Provide engineering support for 24/7 operations, including occasional after‑hours coverage.

Required profile

• Bachelor’s degree in Engineering with 4 + years experience, or Master’s with 2 + years, or Doctorate.
• Proven experience in cGMP environments and pharmaceutical/biotech production.
• Strong independent work ethic, organized, and able to multitask in project settings.
• Excellent written and verbal communication skills.

Required skills

• cGMP procedures
• QRAES
• Change Control
• CAPA (Corrective and Preventive Actions)
• Validation practices
• Maximo
• Purchase Order processing
• Vendor management
• Technical writing

What we offer

• $45 per hour (W2)
• Access to medical, dental, vision and tele‑medicine benefits.
• Life, accident, critical illness and legal insurance options.
• Retirement savings plan, service bonus and paid holidays.
• Transit spending account and paid sick leave.