Manager Validation

Merck Group • $139K — $208K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • B.S./M.S. in a scientific discipline with 8+ years in production, validation, technical support, or quality assurance
  • 5+ years of people leadership and project management experience
  • In-depth knowledge of US and European GMP guidelines and FDA Process Validation Guidelines
  • Familiarity with aseptic pharmaceutical manufacturing processes and equipment
  • Hands-on skills with validation test equipment and strong PC skills for data management and analysis

Responsibilities

  • Define and manage compliant validation programs across various areas
  • Participate in new systems and equipment projects, including budgeting and coordination
  • Manage the site's Revalidation Program across processes and systems
  • Develop validation plans for facility projects and new product transfers
  • Review process changes for compliance with Annual Product Quality reviews
  • Approve validation documents and propose validation strategies for system changes
  • Lead and support validation training and maintenance efforts site-wide

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Opportunities for career development and training
  • Performance-based bonuses
Full Job Description
Your Role:

This position will manage the validation programs and support of all phases of plant operations including on-going operations and projects in the following areas:
  • Aseptic pharmaceutical formulation, filling and packaging
  • Critical and non-critical utility support services (Water for Injection, Compressed Air, Cooling Water, Steam, etc.)
  • Analytical and Microbiological Laboratories
  • GMP-related Computer Systems and Networks


Major Position Activities & Responsibilities:
  • Define and manage all facets of a compliant validation program including process Validation, Cleaning Validation, Shipping Validation, Computer System Validation, Process Media Simulation Program, Laboratory Validation and Equipment Qualification.
  • Participate in projects for new systems and equipment. Associated functions include project estimating and budgeting, scheduling and overall project coordination.
  • Manage the Revalidation Program for the site (processes, equipment, sterilization, cleaning, laboratory, computer systems, etc.)
  • Develop project validation plans in support of small and large facility projects, including new product transfers, raw material qualifications, facility expansions, equipment and system acquisitions and modifications.
  • Review process changes and validation in support of Annual Product Quality reviews.
  • Perform Validation Review and Approval for all validation documents.
  • Review and recommend impact of critical system work orders and change control requests (document changes, physical changes, etc.). Recommend required level of validation and propose plans to maintain systems in a compliant, validated state.
  • Support the media fill program, covering all aseptic manufacturing and filling operations.
  • Assume project validation lead to support projects managed by other departments.
  • Create validation master plans for new systems/processes.
  • Create Standard Operating Procedures (SOP's) and maintain/ update existing SOPs.
  • Create and support the creation of protocols and summary report and technical assessments
  • Acquire and demonstrate the ability to use site documentation systems such as: Quality Tracking System, Document management systems, Training, Maintenance management etc.
  • Interpret study results and raw data. Identify trends, OOSs and determine validation impact
  • Maintain a focus on continuous improvement and ensure that the validation program meets best accepted practices based on current industry and regulatory guidance
  • Provide technical support on process and validation topics in support of compliance audits and investigations
  • Support personnel development and growth of validation staff through training, mentoring, coaching, etc. Provide site-wide training as required to increase awareness and understanding of validation and the site validation program
  • Performs special projects and other duties as assigned.


Scope:
  • Responsible for all aspects of validation program as described above.
  • Responsible for all validation staff department, as well as contractors supporting individual projects.
  • Responsible for Validation Expense Budgets


Who You Are

Minimum Qualifications:
  • B.S./M.S. in a scientific discipline with 8 or more years of experience as a professional in production, validation, technical support or quality assurance functions, some in an area with aseptic pharmaceutical manufacturing.
  • Proven people leadership and project management skills with at least five years supervising people
  • In-depth knowledge of US and European GMP guidelines, federal environmental regulations, especially ICH 8, 9, 10 and the most recent Process Validation Guidelines issued by FDA.
  • In-depth knowledge of process equipment, unit operations, process control systems.


Preferred Qualifications:
  • Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning, and sterility assurance required.
  • Knowledge of various types of validation test equipment, such as: Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.
  • Prior experience in the qualification of various types of sterile filling facility equipment and systems
  • Hands-on skills are necessary.
  • Expertise with Windows based Personal Computers and above average PC skills with spreadsheets, word processing and databases.
  • Employee must be self-motivated, highly organized, and conscientious. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Strong verbal and written communications skills are required.
  • Employee must have sufficient mobility to work in a process environment. The employee will be required to climb stairs and ladders to perform the functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
  • Employee must be available to support off-shift and weekend activities to meet Validation objectives and provide technical support as required.
  • Employee must be self-motivated, highly organized, and conscientious. Effective interpersonal skills are required to interface with internal clients as well as outside contractors. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Excellent verbal and written communications skills are required.
  • Employee must have sufficient physical agility to work in a process environment; the employee will be required to climb stairs and ladders to perform the functions of this job.


Pay Range for this position: $139,100- $ 208,700

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

Keep Up to Date

Stay informed with career tips, insider perspectives, and industry-leading insights from Merck Group professionals. These resources are invaluable for those looking to advance their careers and stay ahead in a competitive job market.

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SEARCH MERCK GROUP JOBS

READ CAREERS BLOG

Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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