August 18, 2022 A Technology Blog

Job Opening for Associate Director of Validation – Utilities & Facilities (PHARMA) in PharmAllies (Research Triangle Park, NC)

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Job Category : Engineering
Company Name: PharmAllies
Position Name: Associate Director of Validation – Utilities & Facilities (PHARMA)
Location : Research Triangle Park, NC
Job Description : RELOCATION TO NEW HAMPSHIRE REQUIREDThis Permanent Full-Time Position offers a unique culture and an exceptionally competitive compensation package.__**(PHARMA) Associate Director of Validation – Utilities & Facilities__**Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel (Full-Time Permanent Positions). This company has the experience, expertise, and a successful track record in developing life-changing pharmaceuticals and medical devices. Together with their clients, they treat many forms of cancers, diabetes, infectious diseases, and many other illnesses. Make a difference. Your work will matter, and your contributions will be significant in these endeavors.Job SummaryThe Associate Director for Facilities, Utilities, Systems, and Equipment will manage all aspects of the site validation lifecycle to assure Facilities, Utilities, Equipment, and Fill/Finish processes operate in a state of control consistently and reliably produce products that conform to specifications. Lead the daily operations of the Validation Team, including validation contractors, in support of 24/7 manufacturing of operations. Develop and execute efficient Facilities, Utilities, Systems, and Equipment validation strategies that meet regulatory requirements and industry standards. In collaboration with validation leadership, ensure changes in regulatory compliance requirements are identified, documented, integrated, and maintained. Support innovation, continuous improvement, and harmonization of workflows, quality systems, and procedural guidance around the Validation of manufacturing processes.Job DutiesLead the Facilities, Utilities, Systems, and Equipment Validation team to ensure that production targets and budgets are met, that product and processes comply with cGMPs and corporate policies, that quality documentation is complete and on time, and regulatory inspections are managed through satisfactoryAccountable for maintaining the site Master Validation Plan and inventory of site Facilities, Utilities, Systems, and EquipmentManage and maintain oversight of the team and approve GXP Assessments for Facilities, Utilities, Manufacturing Equipment, and components to define the collective requirements for Supporting corporate Data Integrity and CSV initiativesManage the process documentation and requirements to include but not limited to the following: Equipment Validation Plans, Cleaning Validation Plans, Utility/Facility Validation Plans, Components Area Validation Plans Environmental Monitoring Validation Plans, Quality Control Validation Plans, Scheduling, planning, and review of Facilities utilities, systems, and equipment validation activitiesApprove User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA)Provide direction and participate in validation protocol development/review and approval. Ensure that validation prerequisites have been properly conducted prior to validation executionCollaborate with other departments and Manufacturing to implement product monitoring activities that provide ongoing assurance that the systems continue to produce products that conform toLead the Facilities, Utilities, Systems, and Equipment team to assesses GMP changes to assure that the validated state and process are in controlEnsure appropriate staffing of team with validation subject matter Provide ongoing coaching and mentoring to assure that team’s competency remains current with changes in regulatory and industry standardsAssure consistent execution across the team to standardize approaches to Validation that are efficient, effective, and Provide training for other functions, as required, on validation requirementsInterface with Regulatory agencies and clients, as required, in conjunction with new drug applications, Facility inspections, and technical interchanges to represent the company position with respect toProvide technical support in case of critical process-related deviations in terms of root cause investigation and implementation of corrective and preventiveProvide leadership and direction to staff in relation to Facilities, Utilities, Systems, and Equipment validation strategies for both internal and external (CMO) products Support inspections and audits by clients and regulatory agencies and the timely closure of observations/auditSupport site Validation related activities for the design, commissioning, qualification, and continued Validation maintenance of all Equipment, Facilities, and Utilities, including identification of opportunities for improvementAs a subject matter expert, represent these activities in discussions and communications with Clients and regulatoryEducationBS in Engineering or related Life Sciences with a minimum of (12+) years relevant experience or MS in related field with a minimum of 10+ years relevant experience preferably within a GMP manufacturing CMO (aseptic/sterile product facilities) environment or equivalent experienceProfessional Experience and SkillsProven track record of staff management, capable of developing people and teams with at least 10 years of management experience. Experience in managing contract resources and FTEs to complete C&Q activities, Project management/planning of C&Q execution of a facility start-upExperience in the successful management of complex Validation activities. Familiarity with Quality Management Systems and GxP Regulations.Sterile Fill Finish experience is highly desired. Process Validation experience A PLUSSound industry knowledge, project proficiency, and autonomy are expected. May be considered a Subject Matter Expert (SME) in various disciplines. Prior manufacturing/Facility Startup and FDA PAI experience are preferred.Must possess in-depth knowledge of equipment, Sterile Fill/Finish process, CSV, Utilities, and cleaning validation.Hands-on experience and knowledge of equipment such as Freeze Dryers, Washers, Tunnels, Sterile Filling, Autoclaves, Manufacturing/ Holding vessels, Incubators, CTUs, etc.Excellent written and oral communication to include accurate and legible documentation skills.Demonstrated successful collaboration with multiple functions to coordinate the execution of validation activities and incorporate validation results into routine operational practices.Skilled in regulatory requirements for validation, Aseptic Operations, and Cleaning Validation.Prior experience authoring & executing process validation studies for commercial GMP manufacturing processes including process qualification (IOQ, PPQ, RQ) and managing the validation teamsQualitiesStrong focus on customer service orientation. Highly detail-oriented.A passion for continuous improvement activities to assure impeccable service to the organization and clients.Solid people management and technical skillsPhysical RequirementsMust be able to stand for long periods of time each day.Travel and work at all site locations/Facilities.Ability to successfully prioritize and multitask in an environment with competing demands and at times shifting priorities.Able to do ISO cleanroom gowning and PPE, as required by site procedures.CommunicationInteracts with and Works closely with Engineering, Manufacturing, MTS, Quality, EH&S, Facilities, and ValidationManagerial ResponsibilitiesManagement of contract resources and FTEsTRAVEL – < 10% or >20%_L22-00024Job Type: Full-timePay: From $1.00 per yearBenefits:401(k)401(k) matchingDental insuranceHealth insurancePaid time offParental leaveVision insuranceSchedule:8 hour shiftSupplemental Pay:Bonus payApplication Question(s):Will you now, or in the future require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?Will you be able to commute or relocate to NEW HAMPSHIRE for this job?Education:Bachelor’s (Required)Experience:Pharmaceutical: 10 years (Required)Biopharmaceutical: 10 years (Preferred)Work Location: One location
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