Biotech Manufacturing Specialist – Growth & Remote Options

Mykelly; Juncos (PR); Hybrid; USD 44,000 - 61,000; Full time

Benefits offered by this job

Biweekly direct deposit (W-2)

Paid vacation, sick leave, holidays, &

Christmas bonus eligibility

Extensive training resources

Career guidance

Job summary

Kelly Science & Engineering is seeking a Specialist Manufacturing to support manufacturing and quality systems in a premier biotech environment in Juncos, PR. The role involves implementing non-conformances, validation, procedures, training, and new product introductions on an Administrative shift.

Eligible candidates have a Bachelor’s with 4+ years or Master’s with 2+ years in Manufacturing Operations; strong TrackWise/Veeva experience and proficiency in SAP, Smartsheet, and MS Office are

Qualifications

• Bachelor’s degree with 4+ years or Master’s with 2+ years in Manufacturing Operations.
• Strong Change Control experience using TrackWise, Veeva Vault/CDOCs, or similar systems.
• Knowledge of GMP manufacturing operations and regulatory compliance.
• Proficient in SAP, Microsoft Office, and Smartsheet.
• Technical writing and controlled documentation experience.
• Project coordination and management experience; knowledge of control charts.
• Fluent in English and Spanish with strong communication and presentation skills.

Responsibilities

• Support execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.

Skills

Change Control

GMP knowledge

SAP (ERP)

MS Office

Smartsheet

Technical writing

Project coordination

Bilingual English/Spanish

Education

Bachelor’s degree +4 years

Master’s degree +2 years

Tools

TrackWise

Veeva Vault/CDOCs

SAP

Smartsheet

Microsoft Office

Job description

Kelly Science & Engineering is seeking a Specialist Manufacturing to support manufacturing and quality systems in a premier biotech environment in Juncos, PR. The role involves implementing non-conformances, validation, procedures, training, and new product introductions on an Administrative shift.

Eligible candidates have a Bachelor’s with 4+ years or Master’s with 2+ years in Manufacturing Operations; strong TrackWise/Veeva experience and proficiency in SAP, Smartsheet, and MS Office are