Lead Manufacturing Bioprocess Associate-Shift
3 weeks ago
- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 5+ years
- City: Meath
- State/Province: Meath
- Country: Ireland
About PSC Biotech
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 our unique selling points, offering the opportunity to work with a talented cohort of like-minded professionals in the Pharma/Biotech industry. We offer permanent employment contracts, providing exposure to top pharmaceutical client sites in diverse cultural work settings.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech. We provide empowering career development through in-house training, mentorship, and continuous guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations regarding quality, budget, and timelines.
Overview
- An exciting opportunity for a Manufacturing Bioprocess Associate to support manufacturing operations of Late Stage and Launch Pipeline products at our state-of-the-art single-use biotechnology facility in Dunboyne, Ireland.
- The client values diversity and inclusion, fostering a sense of belonging and ownership among employees in Dunboyne.
This role involves supporting manufacturing operations on a shift rotation basis.
Reports to: Drug Substance Process Operations Manager
RequirementsResponsibilities:
- Support end-to-end production operations for both Fed Batch and Continuous Manufacturing.
- Lead and guide team members supporting on-floor manufacturing during shift rotations.
- Provide guidance, coaching, and mentoring to the production team.
- Operate equipment per electronic batch records, sampling plans, and SOPs.
- Work collaboratively within a dedicated process team, emphasizing flexibility and teamwork.
- Problem-solving and continuous improvement mindset.
- Adhere strictly to safety and compliance standards.
- Assist in authoring electronic batch records, sampling plans, work instructions, and SOPs.
- Participate in daily cross-functional team meetings to ensure compliance.
Education:
- Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering.
Experience & Skills:
- Over 5 years of experience in the biotech industry, particularly in bulk manufacturing of pharmaceuticals or biological components.
- Practical troubleshooting and problem-solving skills.
- Ability to work independently and within cross-functional teams.
- Understanding of multi-column chromatography.
- Knowledge of contamination control and batch release requirements.
- Experience with Emerson DeltaV, Pas X, and manufacturing automation.
- Proficiency with Single-Use technologies.
- Experience in managing deviations, changes, and regulatory compliance.
Preferred Experience and Skills:
- Commissioning and Qualification experience.
- Knowledge of upstream and downstream unit operations in biomanufacturing.
- Understanding of continuous and batch-fed manufacturing processes.
- Experience supporting regulatory inspections and internal audits.
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