Automation SME – Project Engineer

Weil Group • Manati, PR

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About The Position

The assigned resource must meet the following minimum qualifications: Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field. Minimum five (5) years of experience in pharmaceutical operations or manufacturing environments with proven project management experience, of which: o At least four (4) years must be in process automation within a pharmaceutical environment o At least two (2) years must be in computerized systems validation (CSV). Demonstrated proficiency in computer system lifecycle concepts, change control processes, and FDA regulatory requirements, including 21 CFR Part 11. Proven experience developing and reviewing Computerized Functional Requirements (CFR/URS) and Design Specifications (DS/FRS). In-depth knowledge of the design, installation, commissioning, and qualification of computerized systems, PLCs, and automation platforms in pharmaceutical manufacturing. Broad knowledge of cGMPs, FDA, EMA, and applicable regulatory guidelines for biopharmaceutical manufacturing facilities. Experience supporting internal and external regulatory audits (e.g., FDA, EMA). Strong understanding of pharmaceutical manufacturing processes, equipment, and automation systems. Knowledge of electrical controls theory, mechanical concepts, and electronic circuitry, with ability to read and interpret electrical and mechanical drawings. Proven skills in project management, systems development, and implementation of manufacturing automation, MES, and quality-related systems. Experience with PLC programming platforms, data acquisition systems, historians (e.g., OSI PI), databases (e.g., MS SQL), and industrial networking infrastructures. Ability to review and support development of SOPs and work instructions. Strong analytical and problem-solving skills, with ability to resolve complex technical issues based on data. Fully bilingual English/Spanish, written and verbal. Strong interpersonal skills with ability to work effectively across all organizational levels and disciplines. Ability to manage and prioritize multiple complex activities simultaneously. Self-starter, well organized, flexible, and able to meet deadlines. Willingness to work irregular hours, weekends, and holidays as required. Ability to exercise good judgment. Weil Group is proud to be an Equal Employment Opportunity Employer.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field.
• Minimum five (5) years of experience in pharmaceutical operations or manufacturing environments with proven project management experience
• At least four (4) years must be in process automation within a pharmaceutical environment
• At least two (2) years must be in computerized systems validation (CSV).
• Demonstrated proficiency in computer system lifecycle concepts, change control processes, and FDA regulatory requirements, including 21 CFR Part 11.
• Proven experience developing and reviewing Computerized Functional Requirements (CFR/URS) and Design Specifications (DS/FRS).
• In-depth knowledge of the design, installation, commissioning, and qualification of computerized systems, PLCs, and automation platforms in pharmaceutical manufacturing.
• Broad knowledge of cGMPs, FDA, EMA, and applicable regulatory guidelines for biopharmaceutical manufacturing facilities.
• Experience supporting internal and external regulatory audits (e.g., FDA, EMA).
• Strong understanding of pharmaceutical manufacturing processes, equipment, and automation systems.
• Knowledge of electrical controls theory, mechanical concepts, and electronic circuitry, with ability to read and interpret electrical and mechanical drawings.
• Proven skills in project management, systems development, and implementation of manufacturing automation, MES, and quality-related systems.
• Experience with PLC programming platforms, data acquisition systems, historians (e.g., OSI PI), databases (e.g., MS SQL), and industrial networking infrastructures.
• Ability to review and support development of SOPs and work instructions.
• Strong analytical and problem-solving skills, with ability to resolve complex technical issues based on data.
• Fully bilingual English/Spanish, written and verbal.
• Strong interpersonal skills with ability to work effectively across all organizational levels and disciplines.
• Ability to manage and prioritize multiple complex activities simultaneously.
• Self-starter, well organized, flexible, and able to meet deadlines.
• Willingness to work irregular hours, weekends, and holidays as required.
• Ability to exercise good judgment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level