About PSC Biotech
Who we are?
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 points which include 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 to 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 through 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 regard to the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.
Key Responsibilities:
Review of P&IDs during commissioning phaseGeneration of Change control and System Impact Assessment (Kneat)Review vendor documents for completenessProvide SAT supportValidation document generation and protocol for equipment, including, but not limited to, process equipment and utility systems, both paper or using e-validation systems (Kneat)Execution of IQ and review/support for OQ.Closure of Change Control implementation tasksWork independently with the project manager, vendors, and contractorsProvide Quality service adhering to SOP requirementsGive necessary support for the timely completion of projectsBe present on-site to provide full-time support.Computerized systems in particular to Agilent LCMS and GCMSTemperature MappingCleanroom Qualification
Job Responsibilities:
Maintain confidentiality of HR related mattersResponsible for supporting and executing a wide range of human resources functions, including recruitment, employee relations, performance management, HR operations, and compliance & other HR modules, be able to provide HR reporting/analysisProvide support in the implementation of HR policies, programs and procedures Responsible for basic IT support which includes laptop logistics such as inventory management, procurement and deployment of laptopsManaging all payroll/staff OT claims and other payroll related matters, submission of CPF/ IR8A & government claimsResponsible for recruitment & talent acquisition related matters such as writing effective job postings and job ads, identifying and developing sources of qualified candidates, initial phone screening, interview scheduling and other tasks as assignedResponsible for new employees on-boarding matters such as developing and implementing new employee orientation program, following new employees through their first month of work to ensure retention and satisfactionIn charge of internal/external training coordination and arrangementAssist in employee relations engagement, enhancement & other related activities, to promote a positive work environment and improve morale of the employeesAssist in performance management processes and support training and development programs for employeesMaintain & update employee records and HR databasesAssist in the provision of regular and relevant HR reports & analysis, including attrition report, organizational climate survey and other reporting as required.Any others HR matters that require follow upBe committed to independence, neutrality and impartiality in dealing with colleagues, customers and supplier; safeguarding the confidentiality of customers and suppliers, will not disclose confidential information to third parties unless prior agreement has been provided
Job Requirements:
Degree or Diploma qualification preferredA minimum of one year of recruiting or Human ResourcesHigh energy and attention to detailExcellent written and verbal communication skillsA demonstrated ability to work well in a team environmentKnowledge of automated recruiting management solutions a plusExcellent Microsoft Office skills specifically Word and ExcelAbility to work independently and as part of a team, self-motivation, adaptability and a positive attitudeExcellent administration skillsExcellent written and spoken English communication skills, with Chinese a bonusGood eye for detailWell presentedTeam player
Core Responsibilities
Execute commissioning and qualification deliverables for facilities and utilities.Author, review, and approve pre- and post-execution validation documents.Ensure adherence to GMP, GXP, and company validation standards.Maintain validated state of equipment, utilities, and facilities.Support CAPA (Corrective and Preventive Actions) investigations for validation failures.Participate in internal/external audits and regulatory inspections.Provide documentation and technical support to sustain compliance.Work with engineering teams on new installations to ensure commissioning documentation meets cGMP requirements.May supervise contract validation resources to ensure timely completion of tasks.
QualificationsEducation: Bachelor’s degree in engineering, Chemistry, Biology, or related life sciences.At least 3 years of CSV/validation experience preferred.Prior exposure to facilities/utilities systems (e.g., HVAC, water systems, cleanrooms).Strong knowledge of GMP/cGMP standards.Ability to author/review SOPs and validation protocols.Good communication skills for cross-functional collaboration.
Major Responsibilities
Oversee the computerized system life cycle and ensure compliance with GxP standards and established procedures.Develop and maintain Computer System Validation (CSV) plans in alignment with 21 CFR Part 11 requirements.Manage deviations, change controls, investigations, and CAPA protocols.Author CSV protocols and related documentation.Review and approve documents before and after execution.
Job Qualifications / Minimum Requirements
At least 3 years CSV exp and 1-year exp with Emerson DeltaV hardware/software system
Primary Role
The role is responsible for ensuring smooth Quality Control (QC) operational activities to support routine testing or new product introductions in line with cGMP, EHS, and regulatory expectations. It focuses on enabling QC functional readiness, infrastructure and instrumentation support, and compliance activities.
Major Responsibilities
Support QC operations by conducting timely testing and release for routine and new product introduction activities.Develop technical competency as a trainer or buddy for new joiners, fostering a collaborative work environment.Act as Subject Matter Expert (SME) for QC operational readiness (e.g., raw material, IP, API/BDS testing), infrastructure/instrumentation needs, and compliance readiness (e.g., track and trend) against cGMP/EHS/regulatory requirements.Author and review laboratory documentation in accordance with global and local procedural standards.Assist in resolving manufacturing or laboratory investigations and exceptions to ensure timely closure.Provide support during internal and external audits, contributing to successful audit outcomes and sustaining licenses to operate.Support QC infrastructure and instrumentation needs, including preventive maintenance, calibration, and technological refresh projects.Contribute to new product introduction activities (e.g., biologics, equipment qualification) to enable successful and timely program launches.Perform any other tasks or projects assigned by the line manager.
Job Qualifications / Minimum RequirementsBachelor’s degree in Sciences (Biological, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (Biomedical, Chemical, Pharmaceutical), or equivalent.Strong analytical thinking with problem-solving and technical writing skills.Self-motivated and able to work independently.Solid knowledge of GMP and experience in laboratory operations.Effective collaborator with cross-functional teams.Ability to work within timelines and meet deadlines.
