About PSC Biotech
Who are we
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Overview:
Reporting to the Engineering Centre of Excellence Lead (for info - snip of sub org below) the Engineering Support Specialist plays a critical role in ensuring the smooth and efficient operation of the Engineering department .This position provides comprehensive administrative and coordination support facilitating effective communication documentation control and training management within the department. The role requires a detail-oriented and proactive individual capable of managing multiple tasks while maintaining compliance with company procedures and quality standards.
Requirements
Role Functions:
- Engineering Department Administration: Manage day-to-day administrative duties within the Engineering department supporting engineers and management to optimize workflow and departmental efficiency.
- Procedure Updates: Assist in the review update and distribution of engineering procedures to ensure all documentation reflects current practices and regulatory requirements.
- Engineering Document Control: Oversee the issuance tracking and retention of engineering documents ensuring all records are accurate up-to-date and compliant with document control policies.
- Requisition and Purchase Order (PO) Administration: Support the procurement process by managing requisitions and purchase orders related to engineering projects liaising with suppliers and internal stakeholders to ensure timely processing.
- Quality Assurance (QA) Document Room Oversight: Maintain and organize the QA Document Room ensuring secure storage easy retrieval and proper handling of quality-related documents.
- Meeting Room Coordination: Manage meeting room bookings for contractors and visitors who do not have access to the system as well as coordinate adhoc meeting requests and logistics to support departmental activities.
- Engineering Training Coordination: Coordinate training schedules track attendance and maintain training records for the Engineering department ensuring compliance with internal and external training requirements.
Experience Knowledge & Skills:
- Strong organizational and multitasking abilities
- Excellent communication and interpersonal skills
- Proficiency in document control systems and Microsoft Office Suite
- Experience with procurement processes and PO administration
- Knowledge of quality management systems and regulatory compliance
- Ability to work independently and as part of a team
- Demonstrated ability to work within a regulated manufacturing environment
Qualifications & Education:
Minimum Education:
- Leaving Certificate (or equivalent secondary education qualification) is required.
- A relevant third-level qualification (e.g. Level 6 or 7 on the National Framework of Qualifications in Ireland) in Engineering Business Administration Quality Management or a related discipline is highly desirable.
Preferred Qualifications:
- Diploma or certificate in Engineering Technology Quality Assurance or Document Control.
- Training or certification in Quality Management Systems (e.g. ISO 9001 GMP) is an advantage.
Additional Skills and Competencies:
- Strong IT skills including proficiency in Microsoft Office (Word Excel Outlook PowerPoint).
- Familiarity with document management systems and electronic quality management systems (eQMS).
- Excellent organizational and communication skills.
Engineering Department Administration: Manage day-to-day administrative duties within the Engineering department, supporting engineers and management to optimize workflow and departmental efficiency. Procedure Updates: Assist in the review, update, and distribution of engineering procedures to ensure all documentation reflects current practices and regulatory requirements. Engineering Document Control: Oversee the issuance, tracking, and retention of engineering documents, ensuring all records are accurate, up-to-date, and compliant with document control policies.
Education
Leaving Certificate (or equivalent secondary education qualification) is required. A relevant third-level qualification (e.g., Level 6 or 7 on the National Framework of Qualifications in Ireland) in Engineering, Business Administration, Quality Management, or a related discipline is highly desirable