Associate Director, Engineering- Validation
Associate Director, Engineering- Validation
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Job Description
Job Description
Job Description:
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69000 employees operating in more than 140 countries we offer state of the art laboratories manufacturing plants and offices that are designed to inspire our employees as we learn develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the worlds biggest investors in Research & Development.
We are seeking individuals with strong scientific and technical skills to contribute to the design development and manufacturing of sterile products making accessible our companys next generation of vaccines and biologics. To this end we strive to create an environment of mutual respect encouragement and teamwork. As part of our team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Validation organization at our Durham North Carolina facility is seeking to hire an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate with their colleagues in other areas of the organization as well as all areas of their primary support facility (i.e. Sterile Supply Lyophilization and Filling) and cross-functional teams (i.e. Tech Ops Maintenance Quality Automation and Operations) to ensure a successful Validation support of the vaccine manufacturing facilities.
The Associate Director Validation will be responsible for providing Validation leadership as part of the Vaccine Manufacturing Facilitys Validation team within the Technical Operations organization.
Position Responsibilities:
Reporting to the Director Validation the incumbent will lead the team of validation engineers responsible for Validation activities in all areas of the facility.
Effectively manage a team of Validation engineers by maintaining a culture that defines a High-Performing Organization including proactively providing developmental support coaching and assistance to team members.
Responsible for all Human Resource activities including one-on-one meetings team development hiring talent assessment and performance reviews.
Responsible for the facility requalification program ensuring execution and closeout of requalification activities in accordance with the requalification plan and corporate guidelines.
Manage supplemental contracted Validation partners and strategically balance the team structure to support project scope changes and priorities.
Manage the proposals budgeting and forecasting needs for the contracted validation partners.
Prioritize team safety environmental and compliance objectives.
Lead facilitate and participate on cross-functional teams to collaboratively address issues and achieve milestones.
Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
Author review and/or edit technical documents to support regulatory filings
Author and approve validation procedures in accordance with our Company guidelines
Support both internal and regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors as needed.
Act as a validation subject matter expert in support of quality risk assessments and regulatory inspections.
Partner with other area Validation leads to for alignment organizational strategy and opportunities to provide support across the areas.
Deliver validation-related projects including planning protocol generation execution and summary of results in technical reports.
Manage timely implementation and closeout of validation deliverables to meet production and supply timelines.
Stay abreast of current trends in industry and innovate to drive continuous improvement.
Represent the site in internal collaborations through our Manufacturing Division Validation Communities of Practice to include the sharing of best practices in validation and investigation activities.
Support creation of departmental budget and monitor actual performance against the forecast.
Required Experience and Skills:
Bachelors Masters or Doctorate degree in chemical engineering biochemical engineering biological systems engineering biology biochemistry chemistry or related life science or engineering discipline.
Minimum of 4 years (Doctorate) 6 years (Masters) or 8 years (Bachelors) experience performing validation activities in a cGMP setting including prior people management experience.
Strong understanding of Cleaning (CIP COP) and Sterilization validation (SIP autoclaves depyrogenation ovens) principles and application
Effective decision making problem solving and communication skills. Ability to manage multiple priorities and complex problems in a fast-paced environment.
Aseptic manufacturing and GMP manufacturing experience.
Strong planning scheduling and time management skills
Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
Strong oral and written communication skills
Strong problem solving and technical writing skills
Preferred Experience and Skills:
Experience using Lean/Six Sigma tools.
Experience with the validation of autoclaves parts washers lyophilizers portable equipment tanks/vessels and filling lines
Strong familiarity with eVAL/Kneat
Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
Experience with responding to regulatory questions with multiple agencies (e.g. FDA EMA)
Experience with face-to-face presentation of technically complex subjects to regulatory inspectors
The ability to work well under pressure and achieve results within tight deadlines
Financial acumen
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The salary range for this role is
$139600.00 - $219700.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive if applicable.
We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
TBDRequired Skills:
Ability to Work Under Pressure API Manufacturing cGMP Regulations Change Control Systems Chemical Engineering Chemical Process Development Cross-Cultural Awareness Cross-Functional Teamwork Equipment Qualification GMP Compliance Management Process Manufacturing Process Validation People Leadership Process Optimization Quality Risk Assessment Regulatory Inspections Regulatory Requirements Scope Change Management Strategic Thinking Technical Guidance Technology TransferPreferred Skills:
Job Posting End Date:
06/19/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
