Singapore, Singapore · Remote OK
About the Role We are hiring experienced and motivated Commissioning and Qualification Engineers. Engineers will be responsible for developing commissioning and qualification protocols for a variety of utilities, facilit…
Skills: KNEAT, Commissioning and Qualification, Risk-Based Validation, Technical Writing, Regulatory Compliance
Rockville, Maryland, United States · On-site
$180k–$200k/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: IT Program Management, M&A Divestiture, Infrastructure Separation, Application Separation, Data Center Migration
Melbourne, Victoria, Australia · On-site
POSITION SUMMARY: We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract. The Senior CQV Engineer is responsible for ensuring systems, facilities, …
Skills: Commissioning, Qualification, Validation, CQV Protocols, GMP
Melbourne, Victoria, Australia · On-site
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Commissioning, Qualification, Validation, GxP Compliance, Protocol Writing
Columbus, Ohio, United States · On-site
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Computerized System Validation, Automation Software, cGMP, GAMP 5, 21 CFR Part 11
Melbourne, Victoria, Australia · On-site
About the Role We are seeking an experienced Process & Commissioning Engineer to support a 12‑month manufacturing project based in Melbourne. This role will play a critical part in upgrading and enhancing GMP manufacturi…
Skills: Commissioning, Qualification, Process Optimisation, GMP Compliance, IQ/OQ/PQ
York, Pennsylvania, United States · On-site
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and co…
Skills: Analytical Skills, Problem Solving, Interpersonal Skills, Communication, Teamwork
Brisbane, Queensland, Australia · On-site
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Commissioning, Qualification, Validation, Protocol Writing, cGMP Compliance
Brisbane, Queensland, Australia · On-site
About the Role We are seeking Process Engineers to support ongoing process development and manufacturing scale‑up activities within a GMP‑regulated environment. This role will play a key part in ensuring production readi…
Skills: Process Development, GMP Compliance, Equipment Commissioning, Aseptic Processing, Tech Transfer
Melbourne, Victoria, Australia · On-site
POSITION SUMMARY: The Project Engineer is responsible for delivering capital engineering projects across the full project lifecycle, from design and scoping through procurement, installation, commissioning, and qualifica…
Skills: Project Management, Capital Engineering, GMP Compliance, Equipment Commissioning, Equipment Qualification
Sydney, New South Wales, Australia · On-site
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Commissioning, Qualification, Validation, GxP Compliance, Protocol Writing
Melbourne, Victoria, Australia · On-site
POSITION SUMMARY: We are looking for a Fill Finish Engineer to join our team on a 12-month contract. The Fill Finish Engineer will play an essential role in supporting the technical transfer of processes and products int…
Skills: Fill & Finish Validation, Process Engineering, cGMP, Sterile Filtration, Isolator Qualification
Brisbane, Queensland, Australia · On-site
We are looking for a Computer Systems Validation (CSV) Engineer to join our team on a 12-month contract. The CSV Engineer will be responsible for assisting in planning, writing, implementing, and reviewing validation pro…
Skills: Computer Systems Validation, Validation Protocols, IQ/OQ/PQ, RTM, Test Scripts
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Develop commissioning and qualification protocols for utilities and equipment using KNEAT platforms within the life science industry. Collaborate with cross-functional teams to assess risks and generate comprehensive validation documentation.
Requires a Bachelor's degree in engineering and 3-5+ years of experience in pharmaceutical, biotech, or medical device industries. Must have proven expertise in KNEAT systems and risk-based commissioning methodologies.
About the Role
We are hiring experienced and motivated Commissioning and Qualification Engineers. Engineers will be responsible for developing commissioning and qualification protocols for a variety of utilities, facilities, and equipment in the pharmaceutical, medical device, and biotech industries. Successful candidates will possess expertise in KNEAT validation processes and methodologies, with experience integrating KNEAT solutions in risk-based commissioning and qualification strategies.
Responsibilities
Qualifications
Trusted cloud software for efficient businesses.
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers. To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
Trusted cloud software for efficient businesses.
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers. To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
