Sr. Validation Manager
Company: Renaissance Services
Posted on: September 23, 2022
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
This position is responsible for Validation activities (i.e.
included but not limited to Manufacturing and packaging equipment
qualification, Process validation activities, Cleaning and
Sterilization validation activities), that supports commercial and
new R&D drug development activities in support of Renaissance's
specific client projects involving all delivery systems
manufactured in Lakewood, NJ plant.
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
This position will also interact frequently with
regulatory/compliance personnel at Renaissance. It will assure
compliance to all FDA and international regulations with regard to
validation activities. The employee in this role must be able to
represent Renaissance with customers and senior management.
Carry out team lead / team oversight responsibilities in accordance
with 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
--- Manage variety of complex issues in associated projects, plans
and schedule project implementation. Responsible for defining scope
of work for 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
--- 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
--- 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 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
--- 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 following areas of
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 performing statistical analysis
and evaluation of data to draw technical conclusions and make
--- Review and approval of Master Batch Records. Ensure content of
batch records meet 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 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
Familiarity with current industry practices and guidelines
including those required / outlined by the FDA, ISO, EU and
Keywords: Renaissance Services, Lakewood , Sr. Validation Manager, Executive , Lakewood, New Jersey
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