Assoc. Director, Manufacturing Automation Computer Validation

West Point, PA, US
May 15 2018
Organization Type
Requisition ID: BUS002730

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. 

Position Description 

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:


Validation (Quality)Planning

Quality RiskManagement assessments and plans addressing patient safety, data integrityand product quality.

Release of thesystems for use


Systems qualificationand verification

Validation summary

Retirement anddecommissioning


Andemploying technologies including:


DistributedControl Systems (DCS)

SupervisoryControl Systems (PLC/SCADA)

ManufacturingExecution Systems (MES)

ProcessData Management Systems

ProcessData Analytics Systems

ITIntegration Services


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

Position 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. 
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to   Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement

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

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