Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Product Manager

Reference Standard Coordinator

Talent Partner- Executive Search and Talent Pipelining

Staff Electrical Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Job Description: <ul><li>The role of a Manager – R&amp;D (Research &amp; Development) F&amp;D (Food &amp; Drink) Emulsions typically involves overseeing the research, development, and innovation of emulsions used in the food and beverage industry.&nbsp;</li><li>The manager leads the R&amp;D team to develop new emulsion-based products or improve existing ones to meet customer requirements, industry standards, and market demands.</li></ul> Responsibilities: Planning of Project technical feasibility experiment: <ul><li>End to end planning for Resource availability on time Planning of developmental trials, PDR studies/QBD additional studies for ANDA products</li><li>Planning of developmental trials, PDR studies/QBD additional studies for ANDA products.</li><li>Monitoring of development trials.</li><li>Compilation of the development data.</li><li>Ensuring development as per QBD approach</li><li>Review the technical documents e.g. DMBD, PDR and other protocols &amp; reports.</li><li>Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time project execution.</li><li>Technology transfer of Drug product [ANDA, 505 (b)(2), Complex injectables]</li><li>Exhibit batch execution [ANDA, 505 (b)(2), Complex injectables]</li><li>Support for Process validation and commercial batches [ANDA, 505 (b)(2), Complex injectables]</li><li>Technology transfer documents review Products developed by CRO as per regulatory requirement.</li><li>Support &amp; coordination with CMOs for successful technology transfer</li><li>Fulfilling the regulatory requirements by designing the trials</li><li>Training &amp; knowledge enhancement of the team</li><li>Design &amp; Authorization of SOPs</li><li>Execution &amp; approval process of New Equipments/Instruments for projects in upcoming portfolio &amp; continuous improvement of Development Lab.</li><li>Adoption of GQP (Procedures integration with systems)</li></ul> Requirements: <ul><li>3–4 years of team handling experience</li><li>3–4 years of hands-on work in emulsions (oil-based and water-based)</li><li>Full product lifecycle exposure: development → scale-up → filing</li><li>Minimum 5–10 regulatory filings (e.g., ANDA, NDA)</li><li>Strong people management and leadership capabilities</li><li>Preferred experience in ophthalmic formulations</li><li>Background in injectable manufacturing environment is an added plus</li></ul>

Role Description: <ul><li>The Product Manager develops and helps execute product-level strategies.</li><li>Strategies will be based on market analysis, company objectives and product profitability, and will include recommendations on market share targets and customer bid tactics.</li><li>This position will also develop forecasts for existing and new products and work cross-functionally with Finance, Sales, Supply Chain, Portfolio Management and Regulatory.</li><li>The role requires having oversight of the commercialized products and near-term launches, providing inputs to long-range business cases and plans, and preparing support documents &amp; analytics for execution of sales activities.</li></ul> Responsibilities: Product Strategy <ul><li>Analyze market landscape using IQVIA and other data sources.</li><li>Recommend market share targets based on current share, # of competitors, cost position, supply capabilities and other factors.</li><li>Maintain product dashboard that provides relevant information to management and cross-functional team.</li></ul> Forecasting &amp; S&amp;OP <ul><li>Update and provide by-sku / by-customer forecasts to Finance and Supply Chain for use in official financial forecasts, incentive comp and supply plan forecasts.</li><li>Calculate and report forecast accuracy and customer award compliance measures.</li><li>Develop new forecasting tools and optimize existing models.</li><li>Support the Sales and Operations Planning (S&amp;OP) process reviews.</li></ul> New Products&nbsp; <ul><li>Co-lead the launch preparation process with the Launch Management team.</li><li>Work closely with Portfolio Management on business cases in order to prioritize launch sequencing and justify development/licensing/acquisition of new products.</li></ul> Other Commercial Operations Support <ul><li>Provide supporting documentation to Sales team such as sell sheets, analysis and other items needed to execute sales tactics.</li><li>Co-ordinate with cross functional team and ensure product information updated on our client portal.</li><li>Work with sales team and consultant to create and maintain VA website login.</li><li>Other items as assigned/identified.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in business, Finance, Analytics preferred.</li><li>MBA or masters degree in Analytics/Statistics preferred.</li><li>Minimum 3 years of generic pharmaceutical industry experience in inline/pipeline forecasting or Data Analytics.</li><li>Intellectual curiosity to go beyond the numbers/bring strategic ideas and insights.</li><li>Strong technical skills to build analytical tools, leverage secondary data and rollout plans.</li></ul> Knowledge <ul><li>Expert with MS office Suite, primarily MS Excel?Experience with SAP, Salesforce and IQVIA a plus.</li></ul> Skills &amp; Abilities <ul><li>Self-direct activities based on general direction given.</li><li>Handle multiple projects in a fast-paced team environment.</li><li>Identify priorities based on profitability and company objectives.</li><li>Create detailed business analysis, outlining problems, opportunities, and solutions.</li><li>Excellent analytical, mathematical, and creative problem-solving skills</li><li>Collaborate cross-functionally with Sales, Finance and Procurement colleagues to develop, analyze and implement strategic plans that maximize profitability.</li><li>Develop and maintain decision support systems that collect and synthesize sales data into knowledge that drives management decisions including resource allocations, opportunity identification, performance against expectations, and sales incentives.</li><li>Expand knowledge and experience by regular engagement with key stakeholders to understand business processes, policies, strategies and evolving business trends.</li><li>Interact with the team, management, and across departments to communicate changes to both current and proposed forecast changes.</li><li>Provide feedback and follow up communications across organization on any issues or market challenges.</li><li>Closely monitor the changing competitor landscape, turning insights into actionable and appropriate product strategies.</li><li>Review and recommend key products to stimulate profitable sales.</li><li>Ability to perform product profitability analyses and run multiple, complex scenarios and present to management for review/approval.</li><li>Brainstorm both short-term and long-term sales and profitability milestones and goals.</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

About the client Our client is a global leader in talent solutions following a transformative partnership that creates a new market leader. With over three decades of trusted expertise and offices across the USA, UK, Switzerland, Hungary, Poland, Dubai, India, Singapore, and Hong Kong, they work with the worlds most influential and respected businesses on a truly global scale. They deliver research-driven talent mapping, pipelining, and executive search services to Fortune 500 and FTSE companies worldwide, utilising their cutting-edge talent intelligence capabilities to help organisations attract, hire, and retain exceptional talent across all markets. Role Purpose: <ul><li>The Talent Partner (Executive Search and Talent Pipelining) specialises in executive search to support leadership recruitment across our life sciences portfolio.</li><li>This role combines executive recruiting expertise with partnership skills to identify, attract, assess, and secure top tier talent.&nbsp;</li></ul> Responsibilities: Executive Search Recruiter: <ul><li>Partnering with TA teams and senior stakeholders to support comprehensive executive talent strategies aligned with business objectives and succession planning</li><li>Supporting complex executive search assignments for leadership positions</li><li>Building and maintaining executive talent pipelines</li></ul>&nbsp;Executive Candidate Experience: <ul><li>Delivering white-glove candidate experience throughout the executive search process from initial confidential outreach through successful placement</li><li>Conducting in-depth executive interviews focusing on leadership competencies, strategic thinking, and cultural alignment</li><li>Managing complex offer negotiations involving equity packages, executive compensation, and relocation requirements</li></ul>&nbsp;Search Process Excellence &amp; Market Intelligence: <ul><li>Executing comprehensive executive search methodologies including market mapping and competitive intelligence</li><li>Conducting advanced market research including industry analysis, compensation benchmarking, and talent landscape assessments</li><li>Developing comprehensive market reports and talent mapping studies for client presentations</li><li>Maintaining executive network and industry relationships for future search opportunities</li></ul> Requirements:&nbsp;Personal Attributes: <ul><li>Highest level of professionalism and discretion when handling confidential executive information</li><li>Cultural sensitivity and global perspective for international searches</li><li>Resilience and adaptability in managing high-stakes, complex search assignments</li></ul>&nbsp;Preferred Qualifications: <ul><li>Bachelors degree is a plus; MBA or advanced degree preferred, ideally with life sciences/pharmaceutical/biomedical or similar</li><li>Preferred experience within recruitment or professional environment</li><li>Life sciences industry knowledge or relevant experience preferred</li></ul>

Responsibilities: <ul><li>Technical Leadership: Lead multiple advanced technology projects from concept through transfer, ensuring alignment with customer needs, market demands, and industry standards.</li><li>Convert trends into actionable technical roadmap recommendations.</li><li>Innovation &amp; Development: Act as subject-matter expert in cable and interconnect design (analog and digital), including modeling, simulation, and testing.</li><li>Cross-functional Collaboration: Work closely with global engineering and cross-functional teams, managing project budgets, schedules, and deliverables while ensuring strong communication to all stakeholders.</li><li>Documentation &amp; Compliance: Develop and maintain engineering documentation (design specifications, test plans, qualification reports). Ensure compliance with medical device industry standards.</li><li>Mentorship: Mentor and coach junior engineers, providing technical guidance and knowledge transfer.</li></ul> Requirements: Education: <ul><li>Bachelor’s degree in Electrical Engineering (with 8+ years of experience), OR</li><li>Master’s degree in Electrical Engineering (with 6+ years of experience).</li></ul> Experience: <ul><li>Proven experience in electrical interconnect and cable modeling/design/testing.</li><li>Preference for experience in medical device development.</li></ul> Technical Expertise: <ul><li>Proficiency in electrical interconnect modeling, simulation, and signal integrity analysis.</li><li>Hands-on experience with TDR and VNA characterization, high-speed signal testing, and application of transmission line theory.</li><li>Strong experience with full-wave electromagnetic simulations (e.g., Ansys HFSS, Maxwell, SI Wave).</li><li>Data analysis and scripting for test automation.</li><li>Electrical design experience with microcontrollers and embedded systems.</li></ul> Project Leadership: <ul><li>Demonstrated success in leading cross-functional and multi-site technical projects.</li><li>Communication &amp; Collaboration:</li><li>Excellent written and verbal communication skills.</li><li>Ability to collaborate effectively across multiple geographies.</li></ul> Personal Attributes: <ul><li>Self-motivated, adaptable, quick learner, and able to work independently while contributing to team success.</li></ul> Preferred Qualifications <ul><li>Familiarity with catheter-based medical devices and their regulatory standards.</li><li>Knowledge of EMI/RFI characterization for cables and connectors.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.</li><li>Support equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.</li><li>Assist in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.</li><li>Troubleshoot mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li></ul> Requirements: <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.</li><li>Experience with isolator-based sterile filling equipment and cleanroom protocols is highly desirable.</li><li>Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Working knowledge of cGMP, aseptic techniques, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a cleanroom-based pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Role Description: <ul><li>The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.</li><li>The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.</li></ul> Responsibilities: <ul><li>Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.</li><li>Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.</li><li>Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.</li><li>Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.</li><li>Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.</li><li>Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.</li><li>Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services. 11.	Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in mechanical, Electrical, Industrial, or Facilities Engineering.</li><li>3+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering.</li><li>Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.</li><li>Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.</li><li>Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.</li></ul> Skills/Competencies: <ul><li>Expertise Experience in facility system design, commissioning, and lifecycle maintenance.</li><li>Strong project management and contractor/vendor coordination capabilities.</li><li>Excellent problem-solving and root cause analysis skills.</li><li>Strong understanding of aseptic manufacturing facility requirements and environmental controls.</li><li>Effective communication and cross-functional collaboration skills.</li><li>High attention to detail, safety, and compliance.</li><li>Ability to thrive in a dynamic greenfield/startup environment.</li></ul>

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38 pharmaceuticals Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Product Manager

Reference Standard Coordinator

Talent Partner- Executive Search and Talent Pipelining

Staff Electrical Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

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38 pharmaceuticals Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Product Manager

Reference Standard Coordinator

Talent Partner- Executive Search and Talent Pipelining

Staff Electrical Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

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COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.