Primary focus includes responsibility for Technical Operations in our Manufacturing Division, shop floor automation, engineering and adherence to safety standards
Promotes the behaviours and principles that drive continuous improvement of our Lean Enterprise.
Ensures that objectives are achieved at the lowest cost consistent with our company, and local code requirements for employee and environmental safety and health with harmonious employee relations.
- Ensure compliance with the company’s global policies, procedures and guidelines, regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Provide leadership, coaching, mentoring and training to the Engineering and Technology team as required.
- Deliver performance management and succession planning process for Technical Operations.
- Manage the introduction of new or transferred products to site, including assistance with specification, testing, qualification and operation of new capital packaging equipment, ensuring timely use, efficient performance, successful validation and optimal process capability.
- To investigate and follow up issues arising from packaging deviations, establishing assignable causes for atypical processing events and propose appropriate actions to minimize rework and improve process capability.
- Lead and develop strategies for process and cleaning validation activities on site, provide technical packaging assistance with the preparation of validation protocols and oversee in-process validation sampling.
- Strategically manage innovation and continuous improvement activities within the technical operations activities.
- Manage equipment qualification activities which includes installation, operation and performance qualification (IQ, OQ, PQ)
- Design, specification, procurement, installation, and operational qualification of new packaging tooling
- Manage activities linked with major quality investigations including Data collection and analysis of detailed investigation, root cause identification, and corrective action conclusion
- Manage site specific technology developments
- 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)
Qualification
- Engineer or Pharmacist with minimum 5years of experience in the Pharma industry
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.
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:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Work Week
Shift:
1st – Day
Valid Driving License:
Yes
Hazardous Material(s):
Requisition ID:R108418