Job Description

Are you a seasoned expert in validation activities within the pharmaceutical industry? Do you possess exceptional management skills and a passion for ensuring the highest standards of quality and patient safety? Join our team as a Technical Operations Lead and make a meaningful impact on the health and well-being of patients worldwide.Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. This role reports to Plant Director and above site. This is a 2-year fixed term contract.Role Responsibilities:

• 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 companys 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.
• Successful transfer of packaging components.
• 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) , 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 Required:

• Validation Manager/Validation Engineer with minimum 10 years of experience in the Pharma industry
• Proven management and leadership in an engineering, validation, demonstrated package components and packaging process technical excellence
• Equipment reliability
• Component specification Changes/Change Control
• Capital Projects and equipment qualification
• Continuous improvement
• Demonstrated technical writing, component specification changes, handling of change controls, Investigations, CAPAs and Quality actions
• Thinking strategically and Innovatively

Education:Engineering Degree or Science Qualification.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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch 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: Project Temps (Fixed Term)Relocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 08/8/2024*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.

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