Job Title: Engineering Document Control Manager

Introduction:
We are currently seeking a highly skilled and detail-oriented Engineering Document Control Manager to join our team. This pivotal role is responsible for maintaining the integrity and compliance of all engineering documentation within a fast-paced, GMP-regulated environment. The ideal candidate will have an extensive background in overseeing document control systems, with a particular focus on Equipment Turnover Packages (ETOp) and Vendor Turnover Packages (VTOp). This position demands a professional with a proven track record in managing complex documentation workflows for substantial greenfield projects, particularly in the pharmaceutical sector. The successful candidate will be instrumental in ensuring that our engineering documentation meets the rigorous standards of accuracy, compliance, and efficiency required for successful project delivery.

Key Responsibilities:

• Lead the engineering document control department, ensuring the precision and conformity of all engineering documents, including drawings, specifications, and reports.
• Coordinate and manage the ETOp and VTOp processes, ensuring that all vendor documentation adheres to project timelines and quality standards.
• Develop and implement GMP-compliant document control systems to meet stringent regulatory requirements within the pharmaceutical industry.
• Oversee documentation for extensive greenfield projects, guiding them from inception through to successful operational handover.
• Collaborate with cross-functional teams, including engineering, vendors, and project management, to enhance document handling procedures and uphold regulatory compliance.
• Regularly review and update document control policies and procedures to align with industry best practices and project-specific requirements.
• Provide leadership and guidance to the document control team, fostering an environment of continuous improvement and professional growth.

Required Qualifications:

• A minimum of 12 years of experience in engineering document control, specifically within GMP-regulated pharmaceutical environments.
• Bachelor’s degree in Engineering, Business Administration, or a related field.
• Strong familiarity with ETOp and VTOp processes and a thorough understanding of vendor turnover documentation.
• Demonstrated experience in managing document control for greenfield projects, preferably with budgets exceeding $100 million.
• Prior exposure to large, complex projects in organizations akin to J&J (Johnson & Johnson) or other global pharmaceutical companies.
• Expertise in GMP standards and regulatory compliance as it pertains to document control.

Desired Skills and Knowledge:

• Exceptional organizational and leadership skills.
• Excellent communication and interpersonal abilities to effectively interface with all levels of the organization.
• Proficiency in document management software and tools.
• Keen attention to detail with an analytical mindset.
• Fluency in English, with additional language skills being beneficial.

Tools Required:

• Proficiency in industry-standard document control software (e.g., Share Point, Documentum, Master Control).
• Advanced knowledge of Microsoft Office Suite (Word, Excel, Power Point, Outlook).

Additional Requirements:

• Must be a resident of Costa Rica and available to work on-site as needed.

To apply, please submit your resume, cover letter, and any relevant certifications. We look forward to reviewing your application and potentially welcoming you to our team as the Engineering Document Control Manager, where you will play a vital role in maintaining the integrity of our engineering processes and documentation.