Job Title: Sr. Manager, Validation

Location: US-NJ

Overview:

This position is responsible for Validation activities (i.e. including but not limited to Manufacturing and packaging equipment qualification, Process validation activities, and Cleaning and Sterilization validation activities), that support commercial and new R&D drug development activities in support of our partner's specific client projects involving all delivery systems manufactured in the NJ manufacturing facility.

This highly technical and highly specialized position is responsible for generating, reviewing, and approving protocols, deviations, and reports; as well as scheduling manpower activities, providing internal and external customer feedback, ensuring on-time delivery of milestone activities, project staffing, and overall supervision of direct reports. The individual will be a Subject Matter Expert (SME) expected to oversee the overall validation activities related to the support of commercial manufacturing of pharmaceutical products.

This position will also interact frequently with regulatory/compliance personnel onsite. It will assure compliance with all FDA and international regulations concerning validation activities. The employee in this role must be able to represent well with customers and senior management. Carry out team lead/team oversight responsibilities following the organization's policies. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Responsibilities:

• Manage a variety of complex issues in associated projects, plans, and schedule project implementation. Responsible for defining the scope of work for the functional team.

• Manage, identify, hire, develop, and recognize technical staff; the team may include senior-level validation engineers, junior-level validation engineers, and technicians. Provide technical direction.

• Review and approve complex design concepts and analysis of technologies that incorporate own area of expertise as well as multiple disciplines, as applicable.

• Responsible for policy setting and defining procedures for the staff in accomplishing and documenting projects. Provides input on overall department policy.

• Aligns team goals with organizational goals, as well as projects/activities and refining those projects and/or activities proactively.

• Partner with project managers to determine project priorities, track progress toward project milestones and deliverables, and provide regular project status updates to site management. Schedule, plan, manage, and deploy resources to support validation activities and efforts, as needed, to ensure Renaissance and customer timelines are met.

• Provides leadership to assess and provide guidance and risk assessments regarding validation and compliance requirements in own area of expertise.

• Assist and guides the strategy and requirements of how validation is to be accomplished.

• Approves protocols and support documentation.

• Primary subject matter expert in audits and regulatory agency inspections. Prepares regulatory submissions and presents validation dossiers to regulatory authorities during routine internal, customer, and regulatory inspections.

• Applies specialized knowledge in a creative way to a broad range of difficult problems.

• Supports the development of best-demonstrated validation practices within the validation department, based on current industry practices and guidelines.

• Leads large-scale projects or several small projects with complex features.

• Builds cross-functional networks and effectively influences key stakeholders to advance department and corporate objectives

• Stay current with applicable regulations and industry practices. Provide updates to business areas and update procedures and practices accordingly to align with current regulations and industry standards from FDA, ISO, EMA and any other applicable domestic and international regulation.

• Provide guidance and technical expertise in the following areas of validation -

o Sterilization and aseptic processing validation.

o Cleaning validation of manufacturing equipment.

o Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.

• Develop statistical sampling plans, assess and approve quality attribute requirements, as well as perform statistical analysis and evaluation of data to draw technical conclusions and make decisions.

• Review and approval of Master Batch Records. Ensure content of batch records meets the validated state of the process.

• Provide technical assistance for investigations into process/product issues in support of the validation deviations and review of design requirements for products and or equipment.

• Generate and maintain the site program plans and validation master plan.

Qualifications:

Master of Science degree in a pharmaceutical sciences, pharmaceutical manufacturing or other related field required. Bachelors with relevant experience might be considered.

Minimum two (2) years’ relevant experience performing and managing validation activities within an aseptic pharmaceutical environment is required.

Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.