Job Description
Position Description
This position is a key member of the External Manufacturing & Network Equipment team that will be responsible for leading product/technology transfers to Contract Manufacturing Organizations (CMO) and to serve as a key technical interface liaison with our Company internal packaging sites in the areas of packaging equipment design/development, packaging process and controls and packaging operation.
Under general scientific and administrative direction, the engineer leverages experience gained on scientific, technical, and business issues, to lead project teams and technical staff to solve complex packaging problems. The engineer will demonstrate knowledge, skills and abilities to optimize business, technical, and compliance processes. The person in this position participates in high impact, complex cross-functional and cross-divisional teams and initiatives and provides leadership to achieve project goals. Effective collaboration with teams is essential to meet our Company's goals/objectives. The ability to apply these skills in a fast-paced technical operations environment to resolve issues and meet customer needs in a compliant manner are at the core of this position.
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Some key areas of responsibility include:
- As part of the ExM & Network Equipment team, establishing a calibrated technical oversight approach based on the product type, as well as the capabilities and technical competence of an external partner;
- Technology & Product Transfers, Qualifications, Validations, Process Improvements, and Change Control;
- Assurance of compliant packaging process execution and project management;
- Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining to the external packaging partners;
- Technical aspects of fact finding around quality and supply investigations, including leading root cause analyses, and developing robust preventive actions;
- Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes;
- Supporting technical due diligence assessments;
- Assuring technical site readiness for all new product introductions or technology transfers;
- Participating in periodic Business Review Meetings with external packaging partners;
- Leading complex changes of packaging images and primary, secondary, and tertiary materials;
- Qualification of changes to distribution and thermal transport/storage systems and methods for finished drug products;
- Qualification of functional aspects of container closure systems, such as Child Resistance.
Education Minimum Requirement:
- BS degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similar
Required Experience and Skills:
- 7+ years of experience working in medical device, pharmaceutical or in biotech organization with hands-on experience with packaging operations support, packaging materials/components, and packaging processes.
- Knowledgeable of design control, medical device, combination products, pharmaceutical packaging and related scientific/technical concepts and techniques are highly desirable.
- Desirable to have prior experiences working inside a pharmaceutical packaging facility or in an External Manufacturing technical role.
- Highly proficiency in project management skills, from conception and initiation, through close-out.
- Has a mastery of packaging scientific/technical concepts and techniques, applies and furthers those concepts and techniques to execute in pursuit of resolving scientific/technical packaging issues.
- Significant experience with medical device or combination product transfer, operations support, and materials/components.
- Experience using quantitative decision tools for Risk Management and options analysis.
- Completes activities with the highest regard for all Company divisional and local site procedures for safety, quality, and regulatory compliance.
- Excellent oral and written communication skills
- Proven ability to provide technical leadership and apply technical skills in a fast-paced, complex environment.
- In depth understanding and proven expertise in application of GMP's, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification.
- General understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex task.
- Strong analytical and decision-making skills.
- Demonstrates Leadership Behaviors and Inclusive Behaviors.
Preferred Experience and Skills:
- Proven project leadership/ management and complex problem-solving skills.
- Ability to determine areas of potential risk to business success and generate gap analysis.
- Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes. Significant experience with current Good Manufacturing Practices, Pharmaceutical industry regulations, packaging equipment system life cycle and project management.
- Strong oral and written communication skills.
- Experience with key manufacturing change control compliance systems such as Veeva and/or other similar systems.
NOTICEFORINTERNALAPPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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 another's thinking and approach problems collectively.
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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 presence.This 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$101,100.00 - $159,100.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/26/2024
*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:R306478