ProClinical is advertising a vacancy for a Technical Operations position with a leading pharmaceutical, biopharmaceutical, and medical device capability company. The organisation provides comprehensive platform capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, and cell and gene therapy R&D. The Technical Operations will join this company in their office in Pennsylvania. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
- Participate, author, and provide information in the development of basic technical documents, such as non-conforming events, laboratory investigations, deviations, CAPA's, action plans, and change controls.
- Execute NCEs and investigations ensuring complete and thorough review and timely closure.
- Understand aseptic technique concepts.
- Understand experimental designs for general laboratory methods such as PCR, Cell Culture, Virus Detection Techniques, and Analytical methods.
- Identify unacceptable practices and implement improvements.
- Perform basic analysis, interpret, and draw conclusion of scientific and process data per good document practices.
- Follow compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs).
- Identify, communicate, address, and improve simple cGMP compliance, regulatory gaps, and issues.
- Follow and execute Standard Operating Procedures (SOPs).
- Revise, author, and provide comments as a reviewer to simple SOPs.
- Improve the efficiency and execution of SOPs.
- Improve the efficiency and right-first time (RFT) of BR execution.
- Train others on basic SOPs, equipment, and unit operations.
- Train others on basic Technical Operations SOPs and systems.
- Participate, support, present, and represent as an SME during regulatory inspections and client audits.
Skills and Requirements:
- Bachelor's/Master's/ Ph.D.
- Over 5 years of relevant or equivalent experience.
- Understand operations and functions of equipment.
- Understand solution and material preparation.
- Technical knowledge and background in the pharmaceutical and biotechnology industry.
- An understanding of the application of GMP concepts.
- Ideally, possesses lean/six sigma knowledge and experience.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
- Possess basic knowledge of Out of Specification Results and investigations.
- Possesses basic and fundamental understanding of validation activities.
- Possesses basic and fundamental understanding of material related activities.
- Possesses some proficiency on Master Control.
- Possesses and fundamental understanding of support systems (e.g. LIMS).
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages, and basic algebraic and geometric calculations.
- Clarity of vision at near and mid-ranges (less than 20 feet), depth perception, and ability to identify and distinguish colors.
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
- Based on work assignment, may be recommended to have medical testing in accordance with the company's Occupational Health Program.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Taylor Vile at firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £37000.00 per annum
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