Job Description 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 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.
Requirements Accountabilities: Working as part of an inspection compliance team within client site.
Part of a wider global network team you will have responsibility for the management of our inspection methods, equipment and processes Candidate: Should thrive enjoy working as part of a teams Demonstrate strong problem-solving capabilities Ideally will have worked with or have an interest in Vision systems Should have good communication skills Should have a willingness to learn Should have experience working with equipment (mechanical, electrical) note this can be formal or informal experience.
Have an interest in how things work Authority: Independently perform design and qualification activities Author and / or reviewer of protocols, reports and technical assessments Lead inspection related deviations & investigations Outputs: Support for Manufacturing and commercial activities Qualified vision recipes Problem solving solution and communication of solution to different teams and levels Audit readiness Qualifications: The knowledge and skills necessary to perform the duties of this position are typically acquired through a combination of education, experience and knowledge, or the equivalent.
Engineering or a science related diploma or degree are useful as well as experience in a regulated and or vision related work environment.
Preferred Requirements Should be interested in working in a team of like-minded inquisitive people who serve the operations team by providing solutions to their inspection needs Competencies: Independent thinker with demonstrated skills working in teams Strong Interpersonal and communication skills Demonstrated problem solving skills and a thirst for finding the root cause to a given problem.
Requirements Responsibilities (what does this role do): As an Equipment Engineer General: Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures Coordinate company policies and develop procedures that affect multiple organizational units Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise Maintain project budgets encompassing multiple disciplines for areas within assigned projects Project Management: Supervise, coordinate and review work of a small staff of engineers, associated and/or techniques within area of engineering expertise Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields Application of mature engineering knowledge in planning and conducting projects Coordinate the work of vendors, consultants and engineering firms on development of standard design documents Design Engineering: Work with project managers to complete design and engineering projects within schedule, budget and quality constraints Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity Serves as peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining design methodologies in that area Operations Engineering: Modifications Work with research, manufacturing, process development, utilities, facilities, QA and validation departments in developing requirements and recommendations for large and/or highly complex system modifications.
Support continuous improvements efforts.
Development tasks: Capital projects (Technical specialist) Non-Capital projects (Technical specialist / Project Manager) Authority (what does this role control): Technical projectlead within client site; (contractors/vendors/line technicians) Functional leadership over the supporting staff / engineers within projects; Outputs (what does this role need to deliver): Complete actions and project activities according to the established timelines Optimisation of cost/performance ratio within Engineering Department Contributes to the development of new techniques and procedures Competencies: Solid supervisory skills: Activity planning and oversight Resource allocation Work review for quality, timelines and efficiency Excellent communication skill, both written and verbal.
Self-confident, think in solutions.
Needs to be at ease in a structured environment and reporting.
Good interpersonal skills, team player Ability to adapt interactive style to others Ability to work with various levels, both internal and external parties Ability to manage contractors and vendors; Strong interpersonal, negotiation and persuasion skills; Cost control skills; Demonstrated collaborative conflict resolution skills; Project management skills; Knowledge of validation processes and protocols Knowledge of available external resources; Ability to delegate and manage the project work of others; Ability to provide technical solutions to a wide range of problems; Ability to provide practical solutions consistent with organizational objectives Completion and follow-up skills Demonstrate the client Values Qualifications: The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
Minimum Requirements: BS degree in Engineering, science or related technological field of equivalent combination of education and experience Typically 8+ years of relevant work experience with 6+ years in operations / manufacturing environment In depth disciplinary knowledge Developed project management techniques Direct experience with regulated environment (e.g.
GMP, OSHA, EPA) Occasionally work outside office hours Fluency in English, both in oral and written communication Good written and verbal communication skills Knowledge of (personal) computer software, specifically: MS office Preferred Requirements: Experience with project management and managing relations.
Experience in working with different departments and groups in the organization.
Familiarity with validation processes and protocols Knowledge of (personal) computer software, specifically: SAP
