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Equipment Qualifications Specialist

Company: CORDEN PHARMA BOULDER INC
Location: Boulder
Posted on: July 31, 2022

Job Description:

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2'600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.SUMMARY This position leads the maintenance, organization, and administration of the equipment qualification program at Corden Pharma Colorado (CPC). Creates and continuously improves systems, templates, and other qualification related activities. Routine tasks the candidate will perform includes: leading Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire, working with a cross functional team to support both legacy equipment as well as new equipment installations, ensuring on-time completion per procedural driven requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: Supports the facility and maintenance/engineering departments in the following areas. Ensuring new and legacy qualifications align with SOP requirements Manage equipment qualification catalogue and add new items as necessary Initiate and lead all periodic review cycles for legacy equipment, ensuring on time compliant completionIQ/OQ/PQ/DS/FS/URS draft/review Period review reports draft/review Risk Assessments Cleaning Assessments Owns qualification SOP/program, monitoring industry trends and continuously improving the system as necessaryWriting other protocols and reports as necessary Other duties as assigned LEADERSHIP & BUDGET RESPONSIBILITIES Provide guidance and leadership where appropriate.SAFETY & ENVIRONMENTAL RESPONSIBILITIESEvery individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all of their knowledge, training, ability and experience.QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.EDUCATION and/or EXPERIENCE Four-year college or university program certificate in chemical engineering, chemistry, biochemistry, or related scientific field and 6 years' experience in pharmaceutical manufacturing operations or a combination of education and experience. LANGUAGE SKILLS Ability to read, analyze, and interpret common scientific and technical journals, regulatory and compliance documents. Ability to effectively present information to management and colleagues. MATHEMATICAL SKILLS Competence in scientific mathematical skills and statistics including metric analysis, trending, and reporting.REASONING ABILITY Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.CERTIFICATES, LICENSES, REGISTRATIONS NonePHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand and sit. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.CORE COMPETENCIES These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.Knowledge of current Good Manufacturing Practices, ICH Guidelines, ISPE Commissioning and Qualification Guidance, and other pertinent national and international regulations.Excellent writing, interpretive, presentation, and interpersonal skills.Conflict resolution skills.Understanding of equipment qualification and validation. Analytical skills with the ability to function with interdisciplinary teamsProactive approach to problem solving and resolutionUnderstanding of lab to large scale manufacturing equipment setup and useAbility to work in complex environment with the ability to quickly adjust priorities to ensure continuity in manufacturing Ability to apply attention to detail, regulatory requirements, technical aspects and a practical, defendable, logical approach to problem solving. Demonstrated basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required.Focuses on Results: understands priorities; conveys a sense of urgency and drives to complete tasks; persists despite any obstacles.SALARYActual pay will be based on your skills and experience.BENEFITS401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service Accident planCritical illnessDental insuranceDisability insuranceEmployee assistance programFlexible spending accountHealth insurance PPO/HSAHospital indemnity planID TheftLife insurancePaid maternity/paternity leaveTuition reimbursementWellness ProgramVacation - Three weeks 1st yearVision insurance

Keywords: CORDEN PHARMA BOULDER INC, Boulder , Equipment Qualifications Specialist, Other , Boulder, Colorado

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