validation EngineerPSC Biotech

The work we do at BioTechnique has never been more important-and we are looking for talented candidates to join us. We're growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join BioTechnique and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you'll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We're proud to cultivate a culture that will fuel your passion, energy, and drive.
Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique, you determine what's possible.
POSITION SUMMARY:
The Validation Engineer is responsible
for supporting
ensuring systems, facilities, and equipment meet design requirements. The incumbent is also responsible and accountable for the execution of the PSC mission, "to maintain the integrity and professionalism of our products and services while enabling steady growth and development." This is a remote position, supporting the Eastern Standard Timezone.
DUTIES AND RESPONSIBILITIES:
-Write Process, Cleaning, Sterilization, Equipment and Software qualification protocols for various equipment such as Autoclaves,
Depyrogenation
Ovens,
Lyophilizers
, Filling Equipment, Environmental Chamber and Clean Utilities, to meet project deadlines.
-Conduct statistical analysis of validation test results.
-Perform testing and write reports for executed protocols.
-Investigation/ troubleshooting of validation problems.
-Initiates, authors, revises, reviews, and completes controlled documents for validation projects.
-Support the review and qualify equipment for validation activities.
-Writes and reviews GMP and GDP documents and technical specifications.
-Collaborate with multiple departments on assigned project activities and deliverables.
-Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ
-Support the
development
of SOPs and review final reports.
-Additional duties and responsibilities may be assigned.
Requirements
-Bachelor's Degree in Engineering or related life sciences.
-3-5 years of applicable work experience in the biomedical and pharmaceuticals industry.
-Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
-Proficient in developing SOPS, final reports and validation & quality policies.
-Understanding of developing, executing and maintaining validation procedures and policies.
-Strong understanding of
cGMPs
guidelines.
-Knowledge/understanding of protocol acceptance criteria and can readily identify protocol discrepancies and report them to management in a timely manner.
-Sound working knowledge of various processing equipment, for example (but not limited to) the following:
lyophilizers
, washers, sterilizers,
depyrogenation
ovens, incubators, HVAC systems, freezers, refrigerators, fillers, formulation mixing systems, cleaning (CIP & COP) equipment.
-Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate data to actionable plans; demonstrated ability to develop and implement marketing and product/service.
-Ability to execute and deliver results.
-Excellent communication skills.
-Highly organized in planning and time management, with the ability to multi-task
Tiptopjob

Makati City, Metro Manila
Permanent
Full-time