Senior Specialist Qualification and Validation

Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

For our site in Krems, we are currently looking for a:

Senior Specialist Qualification and Validation (m/f/d)

temporary for 2 years

The primary purpose of the position is to manage and drive Qualification and Validation related activities on site partnering with Site Validation Lead, Quality and Manufacturing whilst ensuring continued compliance with the principles of GMP as defined in current European and Austrian statute and guidance.

Qualification and Validation, Senior Specialist Term is responsible for implementing and managing C&Q-activities, qualification (DQ - IQ - OQ - PQ) as well as re-qualification; and validation as per the Project/Site Validation Master Plans. With expertise, provides support and coaching to the qualification and validation engineers in the team.

Based on the activities on site, this role should support Site Qualification and Validation Lead to setup/execute/track programs for the qualification, periodic review and re-qualification of equipment/systems, aseptic processing (Media Simulation) based on the site qualification and validation approach.

This role is for a 2-year period to support the Krems, Qualification and Validation department to ensure compliant facilities and equipment. The role includes strong partnership with the process experts of the IPTs as well as other stakeholders across the site.

Main tasks

• Leading assigned Qualification and Validation activities
• To be up to date with GMP, Engineering and company standards and effectively applying these standards at job
• Responsible for being compliant with company safety guidelines and must be capable of recognizing unsafe situations and acting to be safe during job
• Issue, execution and maintenance qualification and validation plans to ensure continued compliance, including reports, in line with key site milestones
• Issue of Qualification Plans, Protocols and Reports; support different Equipment and Systems owner's by providing technical knowledge
• Planning and execution of the qualification of equipment and systems as well as validation of processes together with the equipment- and process owner (IPTs) for larger projects in corporation with supporting contractors and vendors
• Management of vendor for C&Q as well as validation activities
• Must be able to track qualification/re-qualification activities and must be able to communicate adequately (verbally/writing) at all levels within organisation
• Cooperation with peers and experts at site as well as within the company network
• Conducting periodic reviews and re-qualification programs are executed in a timely manner and deliverables (reports) are delivered as per the agreed schedule meeting compliance
• Perform Cycle development, Qualification and Re-Qualification of sterilization processes (thermal, chemical, other physical methods)
• Support / own the Risk Assessment Program for Qualification and Validation
• Participation and moderating in Risk Analysis of equipment, systems and processes
• Performing the equipment qualification basics including COTS and packaged equipment
• Responsible for training qualification and validation colleagues on respective topics. Potential to train staff on expertise in various areas
• Participating in Event/CAPA/Change control task management meetings. Providing input/information behalf of Validation department. Communicating the actions/proposals/information to the Validation department
• Supporting Change Management, Deviation Management process and CAPA management process on site and delivering assigned tasks in a timely manner
• Issue and maintenance of standards and standard operating procedures for qualification and validation based on internal and external guidelines and standards
• Planning and execution of Computerized Systems Validation (CSV) in corporation with IT and Process Automation - recipe qualification minimal
• Supporting improvement projects and re-validation activities

Qualification & Skills

• Preferred 5 years of qualification experience in large scale production
• Degree in (bio)Chemistry/Process Technology, Biotechnology, Pharmaceutical Technology, Engineering; or comparable work experience
• Work experience in Manufacturing, Qualification/Validation and/or Aseptic Processing operations in a Pharmaceutical Company
• Strong Knowledge and Hands-On-Experience of (Bio) Process Technology; Microbiology, Aseptic Processing, and Equipment Design
• Experienced in the qualification and validation of cleanrooms, sterilization processes and aseptic process media simulation
• Relative experienced in CSV
• Hands on experience with application of risk management tools
• Hands on experience in typical installation qualification activities (PID walkdowns, Material certificate checks, isometric checks) and operational qualification activities (Functional tests, Temperature mapping)
• Relative experience in project management
• Experience in change management and ability to manage deviations CAPAs
• Experience in the use of continuous improvement tools and methodologies
• Energetic and enthusiastic team player; Innovative mindset; strategic, analytical and problem-solving skills
• Excellent communication, interpersonal and organizational skills
• English and German skills
• Task management skills, ability to lead and motivate individuals (incl. external contractors) to complete tasks; coaching, mentoring of new employees

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:07/19/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R293812