Capital Specialist- Level 1

PSC Biotech® Corporation; Munster; On-site; EUR 48,000 - 64,000; Full time

Job summary

PSC Biotech® Corporation in Ireland is seeking a Capital Specialist to manage day-to-day installation and decommission of laboratory instruments in ADC/CDS, ensuring minimal downtime.

You will validate equipment, maintain asset records, and coordinate with vendors for on-site service, working within the SDLC framework and adhering to cGMP, safety, and environmental standards. Degree in analytical chemistry or related field required.

Qualifications

• BSc. in analytical chemistry, pharmaceutical science or a related discipline.
• Candidate should have exposure to SDLC lifecycle and related technologies.
• Experience with installation and decommissioning of laboratory instrumentation preferred.

Responsibilities

• Install and decommission laboratory instrumentation for ADC/CDS.
• Ensure compliance with cGMP and safety/environmental requirements.
• Validate instrumentation and manage site asset records and PM/PV schedules.
• Coordinate with vendor service engineers for on-site support.
• Oversee ordering and installation of new equipment following SDLC.

Skills

Policies and guidelines

Plant documentation

Laboratory testing and documentation

Validation principles and guidelines

Computer skills

System Development Life Cycle

Project Management

Communication skills

Team and interpersonal skills

Technical report writing

Time Management

Meetings Management

Analytical Problem-solving skills

Planning and Scheduling

Education

BSc. (or equivalent experience base) in analytical chemistry, pharmaceutical science or a related discipline.

Job description

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.

Job Purpose

The role of the Capital Specialist is to ensure the day-to-day installation and decommission of all laboratory instruments, minimizing any downtime in the Laboratory. The role covers Drug Substance and Drug Product instrumentation in clinical and commercial areas for ADC. The Capital Specialist also has responsibilities for management of Analytical equipment installation and decommissions in the CDS department.

Requirements

Principal Accountabilities

• The Capital Specialist has overall responsibility for installing and decommission Laboratory Instrumentation in ADC/CDS. The Capital Specialist will complete installation and decommission activities and use external support as required to meet customer targets.
• The Capital Specialist is responsible for ensuring all Capital installs and decommissioning comply with cGMP, including acting as auditee for this area. The Capital Specialist assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as trade compliance, human resources and spending are also responsibilities of the role for this scope of work.
• Installs all instrumentation in accordance with laboratory validation policies, procedures, and guidelines. Reviews and approves validation activities for instrumentation as required. Responsible for the decommissioning of instruments as appropriate.
• Ensures that all instruments are released in a validated state and setup on a site equipment asset management system so they can be maintained on a PM/PV schedule.
• Responsible for troubleshooting issues with during installation, ensuring that investigations are raised, investigated, and closed out as required and for coordinating with vendor service engineers to come on site.
• Ordering and installing new laboratory equipment, ensuring associated documentation is in accordance with SDLC (System Development Life Cycle).

Special Features

• The incumbent operates as part of a team and is self-directed team in carrying out day-to-day activities.
• On assignment, the incumbent participates in departmental initiatives on improved compliance and quality systems.

Core Competencies

Technical:

• Policies and guidelines
• Plant documentation
• Laboratory testing and documentation
• Validation principles and guidelines
• Computer skills
• System Development Life Cycle

Business:

• Project Management.

Leadership:

• Communication skills both written and oral
• Team and interpersonal skills
• Technical report writing
• Time Management
• Meetings Management
• Analytical Problem-solving skills
• Planning and Scheduling

Educational Requirements:

• BSc. (or equivalent experience base) in analytical chemistry, pharmaceutical science or a related discipline.

Additional Notes:

• Start Date: January
• Team Structure: 4 Capital Teams
• Business Reason: The business requires additional resources to meet site demands for instruments being installed across the ADC and CDS labs.
• Overtime: Not required
• Travel: No travel required
• Shift Pattern: Standard shift pattern, days only
• Work Location: Onsite
• Submission Deadline: 8 October at 12:00 PM
• Candidate Profile: Preference for candidates with stronger/more extensive experience, particularly with the SDLC lifecycle and similar technologies.
• Interview Process: Onsite interview with the Hiring Manager, following CV review.