Biopharma - MSAT Engineer

PES is an international services companyproviding Project Management, Construction Management, Commissioning &Qualification and Automation services to our clients in the pharmaceutical,nutritional and related sectors.

With offices across Europe, Asia and US, our core focus ison consistently delivering high quality outcomes for our multinational clients.

This focus and our people's experience in deliveringconsistent quality results for our clients over the past 20 years have been keyto our success to date.

We are currently looking for Senior MSAT Engineer to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.

Process & Manufacturing Support

• Support manufacturing science and technology activities for upstream and downstream bioprocess operations.
• Provide technical support for process equipment, process improvements, and manufacturing investigations.
• Support execution of process validation and process characterization activities.
• Assist in the implementation of new assemblies, process changes, and equipment modifications.

Risk Assessments & Technical Evaluations

• Perform and support risk assessments (RA) related to: Feed vesselsFermentersGrinder break tanks, CRV systems, Buffer hold vessels, Decontamination autoclaves, Product and buffer bioburden/endotoxin risks
• Support toxicology evaluations and contamination control assessments.
• Conduct bactericidal effectiveness studies for cleaning agents including:30% IPA / 1M NaOH1M NaOH

Cleaning Validation & Qualification

• Develop and execute CIP/SIP qualification protocols and reports for: Feed vesselsFermentersGrinder break tanks, CRV systems, Buffer hold systems, Decontamination autoclaves
• Support cleaning hold time (CHT) and sterilization hold time (SHT) studies.
• Support autoclave qualification activities for new loads and assemblies.

Hold Time Studies & Homogeneity Studies

• Execute and document hold time studies for: Buffers, Process intermediates, New assemblies
• Prepare protocols and reports for hold time studies.
• Support the execution, protocols, and risk assessments.

Validation & Lifecycle Management

• Support filter and resin lifetime studies, including:UF lifetime studies, AEX lifetime studies2nd SEC lifetime studies
• Support PUPSIT implementation and validation activities.
• Participate in equipment train data collection and worst-case soil identification activities.
• Support extractables & leachables (E&L) assessments and contamination control (CC) assessments.

Documentation & Compliance

• Prepare and review GMP documentation including: Protocols, Reports, Risk assessments, SOPs, Technical summaries
• Ensure all activities are performed in compliance with GMP, safety, and regulatory requirements.
• Support audits, inspections, and quality investigations as required.

Requirements

• Bachelor’s degree in Biomedical engineering, Chemical Engineering, Biotechnology, Life Sciences, Pharmaceutical Engineering, or related discipline.
• Experience in pharmaceutical, biologics, or biotech manufacturing environment preferred.
• Knowledge of GMP, cleaning validation, process validation, and contamination control principles.
• Experience with CIP/SIP systems, risk assessments, and qualification activities is advantageous.
• Strong technical writing and documentation skills.
• Ability to work cross-functionally in a fast-paced manufacturing environment.

Preferred Experience

• Biopharmaceutical upstream/downstream processing
• Hold time studies and cleaning validation
• Risk assessment methodologies
• Contamination control and microbiological risk management
• GMP documentation and deviation support

If you'd like to find out about this opportunity or anyother opportunity, please forward your CV to Sruthi Srikanth([email protected]).

If you would like to find out about the latest Jobs andProjects we are involved in then do follow us on LinkedIn:https://www.linkedin.com/company/processengineeringspecialists/mycompany/

PES International operates as an equal opportunityemployer. No terminology in this advert is intended to discriminate on thegrounds of age, race, religion, sexual orientation or any other factors with nobearing to employment skills and we confirm that we are happy to acceptapplications from persons of any background for this role.