Assoc. Director, Manufacturing Automation Computer Validation
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Functional leadershipof Computer Validation practices and procedures for the Digital Shop Floor(DSF) capabilities to ensure the systems and projects are delivered of highquality and in compliance with Merck SDLC. This includes following capital projects and programs through allphases of a project life-cycle including business case, concept,requirements, design, testing, installation, qualification and training. Position will involve working closely withthe customer, technical staff, quality groups and supplier management groupsto ensure a successful implementation.
Providesthe Computer Validation oversight to the DSF capital project management andPlatform CoE teams responsible for the implementation of DSF supportedapplications used by multiple MMD sites and other Merck Divisions. Thisincludes the independent review and oversight of the following activitieswithin the DSF area:
Quality RiskManagement assessments and plans addressing patient safety, data integrityand product quality.
Release of thesystems for use
Systems qualificationand verification
Andemploying technologies including:
DistributedControl Systems (DCS)
SupervisoryControl Systems (PLC/SCADA)
ManufacturingExecution Systems (MES)
ProcessData Management Systems
ProcessData Analytics Systems
The Associate Director must also work closelywith the MMD and IT Quality groups to understand needs and make recommendationsfor business improvements that align with MMD QMS principles. Established abilityto provide feedbackand coaching in a constructivemanner to help others complete System Development Life Cycle validation in accordancewith cGMP and Quality Risk Management principles. Qualifications
Education Minimum Requirement:
B.S./B.A. Degree is required. Engineering, Science, or Information Systems.
Required Experience and Skills:
· B.S./B.A. Degree is required. Engineering, Science, or Information Systems.
· A minimum of 10 years manufacturing and/or quality operation management experience within an FDA and/or EU pharmaceutical, device and biologics environment
· Experience with automation systems for pharmaceutical, biological or bulk-manufacturing facilities is required.
· In-depth understanding of System Development Life Cycle (SDLC) and applications systems development is required.
· Excellent communication skills.
· Ability to lead and participate in highly effective teams in a matrix organization.
· Ability to become influential in his/her area demonstrated by suitable technical degrees and/or experience.
· Ability to work with all levels of business customers in a highly dynamic environment.
· Strong leadership and interpersonal skills in motivating staff and customers in the achievement of shared objectives.
· High personal integrity, credibility, and energy.
Preferred Experience and Skills:
· Experience in laboratory, manufacturing, information and automation systems, or technical support, and interpretation and application of GMP Validation expectations. Strong analytical skills in order to develop and recognize appropriate action plans and how they will impact
operations and compliance
· Other information technology in life sciences or regulated industry experiences a plus.
· Experience and in-depth understanding of System Development Life Cycle (SDLC) and application systems development.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Business/Technical Analysis
Other Locations: Whitehouse Station, NJ, US; Branchburg, NJ, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: No
Company Trade Name: Merck