Job Description
A fantastic opportunity has arisen for a Technical Specialist – Vaccines IPT. The Technical Specialist will provide technical and validation support to the Vaccines IPT team and the role will be reporting to the Vaccines IPT Associate Director.
This is a 23 month fixed term contract.
Bring energy, knowledge, innovation to carry out the following:
- Provide technical support for the vaccine process within the Vaccine IPT.
- Execute process qualification activities and process continuous improvement projects, requalification of equipment, familiarity of utility and facility PQ activities equipment periodic reviews and SDLC periodic reviews.
- Adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
- Technical report writing, statistical analysis of data
- Support the completion of validation projects through adhering to validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support commercial manufacturing
- Adherence to the latest regulatory guidelines.
- Apply Lean Six Sigma and Lean methodologies to drive a culture of Continuous Improvement within the IPT.
- Represent the IPT on cross-functional project teams.
- Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
- Assess and align Technical IPT priorities to the IPT and in turn site strategic map.
- Adherence to highest standards for Compliance (Quality and Safety)
- Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
What skills you will need:
In order to excel in this role, you will more than likely have:
- 3-5 years’ experience as a validation/qualification specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
- Experience in the following areas: Process technical support, technology transfer and equipment requalification and utility PQ activities
- A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
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:
Temporary (Fixed Term)
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/26/2024
*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:R316765