The primary purpose of the position is to provide support for validation and qualification activities at the site whilst ensuring continued compliance with the principles of GMP as defined in current guidelines.
Primary Activities
- Providing Equipment Qualification and Cleaning Validation support for capital projects
- Designing, planning and executing of Equipment Qualification and Cleaning Validation activities in collaboration with equipment/process owners, supporting vendors
- Authoring/reviewing protocols, and ensuring alignment with current guidelines for validation/ qualification
- Supporting project change control documentation and delivering assigned tasks in a timely manner
- Authoring and updating SOPs for Equipment Qualification and Cleaning Validation
- Assessing equipment, utility and/or facility changes for Qualification and Cleaning Validation impact
- Contributing to the execution of the periodic review program to ensure the qualification/validation status remains valid
- Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs) , product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that you become aware of to the Designated Point of Contact (DPOC)
Qualifications/ skills
- Minimum a tertiary qualification in pharmacy or equivalent
- Ability to work in networks and cross-functional teams
- Self-driven, self-motivated and pro-active.
- Excellent writing / documentation skills
- Strong work ethic with patient driven focus
- Adaptability
Experience required
- Projects experience will be an advantage
- Two years of operations experience within a cGMP environment will be an advantage
- Equipment qualification and Cleaning Validation experience will be an advantage
- Must be familiar with GMP systems and how they interlink
- Computer literacy: MS Office, MS Excel, MS Visio, MS PowerPoint
- The ability to work well under pressure and achieve results within tight deadlines
- Communication Skills, Written, Oral and Presentation
- Decision Making
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
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., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
10%
Flexible Work Arrangements:
Not Specified
Shift:
1st – Day
Valid Driving License:
Hazardous Material(s):
Requisition ID:R115018